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With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing. Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely. We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services. We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient. The Lead, Manufacturing Operations is responsible for serving as the subject matter expert and operational lead within GMP manufacturing operations supporting biologics production. This role provides day-to-day directional leadership, coordination, and training for manufacturing personnel involved in upstream and downstream processing activities, including cell culture expansion, bioreactor operations, harvest, purification, filtration, and bulk drug substance manufacturing. The Lead supports batch execution, training, process troubleshooting, documentation review, and operational readiness activities. The Lead, Manufacturing Operations will primarily be responsible for manufacturing operations of Train 2. Train 2 is a production line going from vial thaw in initial thaw and expansion to a 500L production reactor, followed by harvest, to finishing operations in downstream. Example Plan Shifts/Training Schedule: - First 2 weeks: 8 hour shifts, M-F - Next 1-2 months: 10 hour shifts, Mon-Thurs - After 90 days: 12 hour shifts, Sun-Tues & Alternating Wednesdays Schedule is subject to change based on needs. Responsibilities Manufacturing Operations Individual Skills Provide hands-on training for upstream staff to ensure compliance with training on all activities prior to GMP execution. Adhere to appropriate gowning procedures required for working in Class 10,000 and Class 100,000 cleanrooms. Perform operations in a bio-safety cabinet using aseptic technique and maintain asepsis of all closed container sterile processes. Perform upstream production activities including thawing of cell stocks, inoculum train expansions, cell culture maintenance in bioreactors, depth and sterile filtration, and master cell bank and bulk drug substance fills. Monitor processes and results and troubleshoot issues as they arise to ensure process success. Lead and guide associates through process and workflow improvement initiatives. Lead batch readiness activities such as general planning and coordination, material requests and transfer, and material and equipment staging. Setup, operate and maintain downstream bioprocessing equipment including AKTA ready column chromatography skids, FlexAct automation skids, large scale filtration skids, and analytical instruments such as SoloVPE. Perform downstream production activities including depth filtration, purification by affinity, ion exchange, and hydrophobic interaction chromatography, viral inactivation and filtration, tangential flow filtration, sterile filtration, and bulk drug substance fills. Enforce cleanroom standards for cleanliness and order Direct floor operations for multiple projects simultaneously. Make adjustments as necessary to adhere to production schedules. Cross-train on various tasks including autoclaving of assemblies, formulation of buffers, and Downstream operations to support overall success of the Biologics group. Represent departmental activities as needed, including project teams and task forces. Review GMP records for completeness, accuracy, and compliance on a daily basis in conformance with regulatory requirements. Draft, revise and review manufacturing SOPs, master batch records, specifications, and other applicable cGMP documentation. Adhere to quality standards set by regulations and Abzena policies, procedures, and mission. Operate to the highest ethical and moral standards. Adjust to a flexible work schedule including weekend work, as needed. Perform additional duties as assigned. Manufacturing Operations Leadership Lead day-to-day execution of upstream and downstream GMP manufacturing activities. Coordinate manufacturing floor activities and provide real-time direction to manufacturing associates during campaign execution. Support media and buffer preparation, inoculum expansion, bioreactor operations, harvest, chromatography, UF/DF, sterile filtration, and bulk drug substance filling. Ensure activities are performed according to approved batch records, SOPs, and production schedules. Provide hands-on training and qualification support for manufacturing personnel. Review GMP documentation for completeness, accuracy, and compliance. Support deviations, CAPAs, change controls, and quality events. Troubleshoot process, equipment, and operational issues. Champion EHS compliance and safe work practices. Partner with QA, QC, MSAT, Engineering, Facilities, Supply Chain, and Program Management. Team Leadership & Development Train Manufacturing Associates. Provide feedback and review of staff during performance evaluations. Facilitate onboarding and qualification of new employees. Promote a culture of safety, teamwork, accountability, and continuous improvement. Lead daily shift meetings, production reviews, and operational communications. GMP Compliance & Quality Ensure strict compliance with cGMP regulations, company procedures, and regulatory requirements. Review and verify batch documentation for accuracy and completeness. Support investigations, deviations, CAPAs, change controls, and quality events. Participate in internal audits, client audits, and regulatory inspections. Ensure proper documentation practices and data integrity standards are maintained. Process Execution & Technical Support Provide technical oversight for upstream and downstream operations. Support process transfers from development to GMP manufacturing. Assist in process validation, engineering runs, and GMP campaign readiness activities. Collaborate with MSAT, Process Development, and Engineering teams to improve process robustness and efficiency. Troubleshoot manufacturing and equipment-related issues. Safety & Operational Excellence Champion Environmental Health and Safety (EHS) compliance. Ensure safe handling of biological materials, chemicals, and manufacturing equipment. Lead risk assessments and support implementation of corrective actions. Drive Lean Manufacturing and continuous improvement initiatives. Monitor and improve key performance indicators (KPIs) including safety, right-first-time execution, batch success rate, and schedule adherence. Cross-Functional Collaboration Partner with Quality Assurance, Quality Control, Validation, Facilities, Engineering, Supply Chain, and Program Management teams. Support customer visits and client-facing manufacturing discussions as required. Ensure manufacturing readiness through effective planning and material coordination. Qualifications BA/BS degree that included laboratory work in a chemistry, biology, or related field. At least 3 – 4 years of purification experience in a GMP pharmaceutical/biotech environment role. Demonstrate knowledge and understanding of cGMPs and how they apply to responsibilities. Skilled in aseptic handling, including BSC operations to maintain the integrity of sterile systems. Skilled with using single-use technologies Strong technical and mechanical aptitude in bioprocessing. Knowledge of purification using column chromatography Experience leading, training, and coaching peers. Computer proficiency A proven ability to confidently compute basic arithmetic operations. Travel between Abzena sites (local San Diego CA facilities ) as needed. Physical Requirements Ability to stand for 1-2 hours at a time, sit for 2 to 3 hours at a time. Frequently lift and or move objects at least 30 pounds in weight. Stand/walk during entire length of shift. Use arms, hands and fingers to handle, feel or reach. Ability to climb, balance, stoop, kneel, crouch, or crawl. Visual abilities including near and far sight, color, peripheral vision, depth and ability to focus. FLSA: Non-Exempt Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing. Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely. We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services. We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient. The Lead, Manufacturing Operations is responsible for serving as the subject matter expert and operational lead within GMP manufacturing operations supporting biologics production. This role provides day-to-day directional leadership, coordination, and training for manufacturing personnel involved in upstream and downstream processing activities, including cell culture expansion, bioreactor operations, harvest, purification, filtration, and bulk drug substance manufacturing. The Lead supports batch execution, training, process troubleshooting, documentation review, and operational readiness activities. The Lead, Manufacturing Operations will primarily be responsible for manufacturing operations of Train 2. Train 2 is a production line going from vial thaw in initial thaw and expansion to a 500L production reactor, followed by harvest, to finishing operations in downstream. Example Plan Shifts/Training Schedule: - First 2 weeks: 8 hour shifts, M-F - Next 1-2 months: 10 hour shifts, Mon-Thurs - After 90 days: 12 hour shifts, Thurs-Sat & Alternating Wednesdays Schedule is subject to change based on needs. Responsibilities Manufacturing Operations Individual Skills Provide hands-on training for upstream staff to ensure compliance with training on all activities prior to GMP execution. Adhere to appropriate gowning procedures required for working in Class 10,000 and Class 100,000 cleanrooms. Perform operations in a bio-safety cabinet using aseptic technique and maintain asepsis of all closed container sterile processes. Perform upstream production activities including thawing of cell stocks, inoculum train expansions, cell culture maintenance in bioreactors, depth and sterile filtration, and master cell bank and bulk drug substance fills. Monitor processes and results and troubleshoot issues as they arise to ensure process success. Lead and guide associates through process and workflow improvement initiatives. Lead batch readiness activities such as general planning and coordination, material requests and transfer, and material and equipment staging. Setup, operate and maintain downstream bioprocessing equipment including AKTA ready column chromatography skids, FlexAct automation skids, large scale filtration skids, and analytical instruments such as SoloVPE. Perform downstream production activities including depth filtration, purification by affinity, ion exchange, and hydrophobic interaction chromatography, viral inactivation and filtration, tangential flow filtration, sterile filtration, and bulk drug substance fills. Enforce cleanroom standards for cleanliness and order Direct floor operations for multiple projects simultaneously. Make adjustments as necessary to adhere to production schedules. Cross-train on various tasks including autoclaving of assemblies, formulation of buffers, and Downstream operations to support overall success of the Biologics group. Represent departmental activities as needed, including project teams and task forces. Review GMP records for completeness, accuracy, and compliance on a daily basis in conformance with regulatory requirements. Draft, revise and review manufacturing SOPs, master batch records, specifications, and other applicable cGMP documentation. Adhere to quality standards set by regulations and Abzena policies, procedures, and mission. Operate to the highest ethical and moral standards. Adjust to a flexible work schedule including weekend work, as needed. Perform additional duties as assigned. Manufacturing Operations Leadership Lead day-to-day execution of upstream and downstream GMP manufacturing activities. Coordinate manufacturing floor activities and provide real-time direction to manufacturing associates during campaign execution. Support media and buffer preparation, inoculum expansion, bioreactor operations, harvest, chromatography, UF/DF, sterile filtration, and bulk drug substance filling. Ensure activities are performed according to approved batch records, SOPs, and production schedules. Provide hands-on training and qualification support for manufacturing personnel. Review GMP documentation for completeness, accuracy, and compliance. Support deviations, CAPAs, change controls, and quality events. Troubleshoot process, equipment, and operational issues. Champion EHS compliance and safe work practices. Partner with QA, QC, MSAT, Engineering, Facilities, Supply Chain, and Program Management. Team Leadership & Development Train Manufacturing Associates. Provide feedback and review of staff during performance evaluations. Facilitate onboarding and qualification of new employees. Promote a culture of safety, teamwork, accountability, and continuous improvement. Lead daily shift meetings, production reviews, and operational communications. GMP Compliance & Quality Ensure strict compliance with cGMP regulations, company procedures, and regulatory requirements. Review and verify batch documentation for accuracy and completeness. Support investigations, deviations, CAPAs, change controls, and quality events. Participate in internal audits, client audits, and regulatory inspections. Ensure proper documentation practices and data integrity standards are maintained. Process Execution & Technical Support Provide technical oversight for upstream and downstream operations. Support process transfers from development to GMP manufacturing. Assist in process validation, engineering runs, and GMP campaign readiness activities. Collaborate with MSAT, Process Development, and Engineering teams to improve process robustness and efficiency. Troubleshoot manufacturing and equipment-related issues. Safety & Operational Excellence Champion Environmental Health and Safety (EHS) compliance. Ensure safe handling of biological materials, chemicals, and manufacturing equipment. Lead risk assessments and support implementation of corrective actions. Drive Lean Manufacturing and continuous improvement initiatives. Monitor and improve key performance indicators (KPIs) including safety, right-first-time execution, batch success rate, and schedule adherence. Cross-Functional Collaboration Partner with Quality Assurance, Quality Control, Validation, Facilities, Engineering, Supply Chain, and Program Management teams. Support customer visits and client-facing manufacturing discussions as required. Ensure manufacturing readiness through effective planning and material coordination. Qualifications BA/BS degree that included laboratory work in a chemistry, biology, or related field. At least 3 – 4 years of purification experience in a GMP pharmaceutical/biotech environment role. Demonstrate knowledge and understanding of cGMPs and how they apply to responsibilities. Skilled in aseptic handling, including BSC operations to maintain the integrity of sterile systems. Skilled with using single-use technologies Strong technical and mechanical aptitude in bioprocessing. Knowledge of purification using column chromatography Experience leading, training, and coaching peers. Computer proficiency A proven ability to confidently compute basic arithmetic operations. Travel between Abzena sites (local San Diego CA facilities ) as needed. Physical Requirements Ability to stand for 1-2 hours at a time, sit for 2 to 3 hours at a time. Frequently lift and or move objects at least 30 pounds in weight. Stand/walk during entire length of shift. Use arms, hands and fingers to handle, feel or reach. Ability to climb, balance, stoop, kneel, crouch, or crawl. Visual abilities including near and far sight, color, peripheral vision, depth and ability to focus. FLSA: Non-Exempt Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
Description: The Plant Assistant works under the direction of the Area Manager, Plant Manager, or Assistant Plant Manager to support the safe and efficient production of concrete. This role includes general labor, equipment operation, and maintenance duties to ensure smooth plant operations. Essential Functions of the Position: • Perform physical labor tasks such as digging, lifting, carrying, and moving materials. • Operate loaders, yard tractors, water trucks, sweepers, and any other equipment necessary. • Utilize preventative maintenance on all yard and plant equipment to ensure they function properly. • Perform pre-/post-trips on equipment to ensure that the equipment can be operated safely. • Load and unload materials and equipment from trucks and other vehicles. • Maintain a clean and organized work area, including cleaning up debris and waste. • Adhere to all safety regulations and protocols, including wearing appropriate personal protective equipment (PPE). • Communicate effectively with supervisors and coworkers. • Perform other duties as assigned by supervisors or plant managers. • Able to work full time and overtime if needed. • Able to travel and work at other plants when needed. Skills and Knowledge: • Basic mechanical knowledge to assist in diagnosing, reporting, and repairing minor equipment or production issues. • Ability to operate heavy equipment such as loaders, yard tractors, man lifts, etc. • General understanding of equipment safety and maintenance procedures. • Strong communication and teamwork skills. Requirements: • Must have a valid Class C driver’s license. • Must have reliable transportation. • Driver record cannot contain any reckless driving offences, DUIs, leaving the scene of an accident, etc. • Driver record cannot contain more than 1.5 active points in the last 36 months. • Ability to follow written and verbal directions and to complete assigned tasks on schedule. • Ability to read, write, and communicate effectively in English. • Ability to work with supervision, receiving instructions/feedback, coaching/counseling and/or action/discipline. Physical Demands: The physical demands described here represent those that must be met by an employee to perform the essential functions of this job successfully. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential job functions: • Ability to work outside in various weather conditions while sitting or standing for extensive periods of time. • Ability to kneel, reach, or lift to 50 pounds or more. • Ability to climb ladders to access higher elevations on batch plants. Benefits: • Medical Insurance, Dental HMO/PPO, Vision, Basic and Voluntary Life, and Voluntary Accident. • Employee Assistance Program (EAP) • 401 (k) Retirement Plan- Company match • Paid Sick time. • Paid Holidays • Paid Vacations • Direct Deposit • Paid weekly. • Referral Bonus This job description does not imply that the listed duties are the only responsibilities of an employee in this position. Employees may be asked to perform additional tasks as needed to ensure adequate workload coverage. Furthermore, employees must follow any job-related instructions and complete any other duties assigned by their supervisor. This job description does not constitute an employment agreement between the employer and the employee and may be changed by the employer as organizational needs and job requirements of the job change.
Introduction to the Job ASML US, including its affiliates and subsidiaries, bring together the most creative minds in science and technology to develop lithography machines that are key to producing faster, cheaper, more energy-efficient microchips. We design, develop, integrate, market and service these advanced machines, which enable our customers - the world’s leading chipmakers - to reduce the size and increase the functionality of their microchips, which in turn leads to smaller, more powerful consumer electronics. Our headquarters are in Veldhoven, Netherlands, and we have 18 office locations around the United States including main offices in Chandler, Arizona, San Jose and San Diego, California, Wilton, Connecticut, and Hillsboro, Oregon. As a Manufacturing Technician you will build and test sub-systems of the ASML EUV Source, responsible for building and testing laser sub-system modules and validating manufacturing processes. You must be work authorized in the United States without the need for employer sponsorship. Role and Responsibilities Uses standardized tools and electronic equipment (i.e., torque wrenches, electric and pneumatic screwdrivers and ball drivers, lifting equipment, computers, oscilloscopes) to assemble/install/remove or perform testing and troubleshooting. Solders small wires under microscope Trains others on areas of test processes and troubleshooting when required. Performs a variety of moderately complex technical service/support duties requiring specialized knowledge (i.e., sub-assembly, assembly, build, test, R&D, QA). Interfaces with engineers to support special tests and experiments with detailed instructions. Documents and monitors safety or security violations critical to product quality or operations. Uses specialized test equipment such as leak testing, Hi - Pot and alignment instruments. Pressurizes Gas, and Water systems with Helium and troubleshoot failures. Reads and understands business documents such as Bill of Materials, routing sheets, inventory records and work instructions. Applies labels to panels, modules, and doors to cleanliness and workmanship standards. Uses cleaning cloths with Acetone, Methanol, and Isopropyl alcohol to wipe surfaces prior to shipping product. Maintains a clean work area, and is responsible for sustaining 5S standard work areas. Installs electrical connectors to modules. Performs other duties as assigned. Job description subject to change at any time Education & Experience Knowledge base generally requires AS or related degree. Requires a High School Diploma or equivalent. Preferred minimum of two (2) years of experience; may have fewer years of experience with a Bachelor's degree. Associate's Degree in technical or scientific field is highly desired. Experience in using all electronic/pneumatic tools. Skills & Competencies Excellent written and verbal communication skills. Ability to translate, statistically analyze data, and effectively report problems through written and/or graphical formats. Ability to use MS Word, Excel, PowerPoint, and electronic e-mail systems. Ability to read and interpret schematics/drawings. Ability to apply advanced knowledge of Company policies and technical skills in support of multiple products, services and components. Strong Mechanical and/or electronic background preferred. Ability to troubleshoot, identify and correct problems in complex software-driven electronic systems, (not circuit-board troubleshooting). Familiarity with cleanroom protocol is preferred. Full to advanced proficiency with a wide variety of tools and equipment (e.g., oscilloscopes, voltage and current probes, multi-meters, chart recorders, and Helium Sniffers). Work Schedule: 0630-1900 Thursday-Saturday/ Wednesday-Saturday (alternating weekly) Other Information PHYSICAL DEMANDS AND WORK ENVIRONMENT The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee routinely is required to sit; walk; talk; hear; use hands to keyboard, finger, handle, and feel; stoop, kneel, crouch, twist, reach, and stretch. The employee is occasionally required to move around the campus. The employee may occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception, and ability to adjust focus. Can work under deadlines. The environment generally is moderate in temperature and noise level. Must wear all approved cleanroom attire; facemask, hood, coveralls, safety shoes, eyewear & gloves. Must be able to read and interpret data, information, and documents. Can observe and respond to people and situations and interact with others encountered in the course of work. Can learn and apply new information or skills. The current base annual hourly range for this role is currently: $22.90-34.34 Pay scales are determined by role, level, location and alignment with market data. Individual pay is determined through interviews and an assessment of several factors that that are unique to each candidate, including but not limited to job-related skills, relevant education and experience, certifications, abilities of the candidate and pay relative to other team members. The Company offers employees and their families, medical, dental, vision, and basic life insurance. Employees are able to participate in the Company’s 401k plan. Employees will also receive eight (8) hours of vacation leave every month and (13) paid holidays throughout the calendar year. For more information, please contact the Recruiter or click on this link Compensation & Benefits in the US . All new ASML jobs have a minimum application deadline of 10 days. This position requires access to controlled technology, as defined in the United States Export Administration Regulations (15 C.F.R. § 730, et seq.). Qualified candidates must be legally authorized to access such controlled technology prior to beginning work. Business demands may require ASML to proceed with candidates who are immediately eligible to access controlled technology. Inclusion and diversity ASML is an Equal Opportunity Employer that values and respects the importance of a diverse and inclusive workforce. It is the policy of the company to recruit, hire, train and promote persons in all job titles without regard to race, color, religion, sex, age, national origin, veteran status, disability, sexual orientation, or gender identity. We recognize that inclusion and diversity is a driving force in the success of our company. Need to know more about applying for a job at ASML? Read our frequently asked questions . Request an Accommodation ASML provides reasonable accommodations to applicants for ASML employment and ASML employees with disabilities. An accommodation is a change in work rules, facilities, or conditions which enable an individual with a disability to apply for a job, perform the essential functions of a job, and/or enjoy equal access to the benefits and privileges of employment. If you are in need of an accommodation to complete an application, participate in an interview, or otherwise participate in the employee pre-selection process, please send an email to [email protected] to initiate the company’s reasonable accommodation process. Please note: This email address is solely intended to provide a method for applicants to initiate ASML’s process to request accommodation(s). Any recruitment questions should be directed to the designated Talent Acquisition member for the position.
About Synchron Synchron’s vision is to build non-surgical brain–computer interfaces at global scale that protect the fundamental human rights of freedom of expression and autonomy. Our first mission is to develop motor decoders that restore the ability of 15 million people with paralysis to interact with the digital world. Our second mission is to develop whole-brain cognitive decoders that enable hundreds of millions of people with cognitive decline to preserve and expand their agency as cognition changes over time. In pursuing these goals, we aim not only to help humans flourish, but also to drive fundamental discoveries in human intelligence. Our team operates at the intersection of healthcare and technology, translating breakthrough research into real-world, safety-critical systems. Senior Quality Engineer (Operations) Quality Location: San Diego, CA (On-site) Employment Type: Full-Time About the Role As Senior Quality Engineer (Operations), you will serve as the Quality lead supporting Synchron’s manufacturing operations, contract manufacturers, and supplier network to ensure products are manufactured safely, consistently, and in compliance with applicable regulatory requirements. You will partner closely with Manufacturing Engineering, Supply Chain, Operations, and R&D to establish robust manufacturing processes, support design transfer activities, and drive continuous improvement across production operations. You will also assist in the development and implementation of Synchron’s QMS. This is a hands-on role requiring regular engagement on the manufacturing floor, with suppliers, and across cross-functional teams. Key Responsibilities Manufacturing Quality Serve as the Quality representative supporting manufacturing operations and production readiness. Develop and maintain manufacturing quality plans, inspection methods, acceptance criteria, and process controls. Monitor production quality metrics including yield, defects, scrap, and process capability; identify trends and drive continuous improvement. Support manufacturing investigations related to nonconforming product, deviations, and production issues. Lead root cause investigations using structured problem-solving methodologies and ensure timely implementation of effective CAPAs. Support Manufacturing Engineering during implementation of new equipment, tooling, automation, and process improvements. Up to 20% travel expected, primarily for contract manufacturer visits and supplier audits. Process Validation & Manufacturing Readiness Lead or support process validation activities (IQ/OQ/PQ) for manufacturing processes, equipment, software, and inspection systems. Develop validation protocols, reports, sampling plans, and acceptance criteria. Support manufacturing process characterization and statistical analysis. Maintain validated state through periodic review and change assessment. Participate in pilot builds and production readiness activities supporting commercialization. Supplier & Contract Manufacturer Quality Manage quality oversight of suppliers and contract manufacturers. Conduct supplier qualification, audits, performance monitoring, and quality system assessments. Review supplier validation documentation, inspection methods, and process controls. Maintain supplier quality agreements and supplier performance scorecards. Partner with Supply Chain to resolve supplier quality issues and implement corrective actions. Design Transfer & Change Management Partner with R&D and Manufacturing Engineering to ensure successful transfer of new products into production. Develop Process FMEAs, Control Plans, inspection strategies, and manufacturing quality documentation. Evaluate manufacturing impact of engineering changes through Change Control processes. Support Design Reviews with a focus on manufacturability, inspection, process capability, and production scalability. Quality Systems & Compliance Author and maintain manufacturing quality documentation including SOPs, Work Instructions, Inspection Procedures, DHRs, Device Master Records (DMRs), and validation documentation. Support internal audits, supplier audits, FDA inspections, and Notified Body audits. Ensure manufacturing activities remain compliant with FDA Quality System Regulation, ISO 13485, and applicable international standards. Support implementation and continuous improvement of Synchron’s Quality Management System. Continuous Improvement Drive Lean Manufacturing and Operational Excellence initiatives. Utilize SPC, capability studies, MSA, Gage R&R, and statistical tools to improve manufacturing performance. Develop quality metrics and dashboards to support management review. Champion risk-based decision making throughout manufacturing operations. Required Qualifications Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, or a related technical/science field 7+ years of quality engineering experience in an FDA-regulated medical device environment, with hands-on experience supporting development and manufacturing of mechanical and/or electrical devices, including process validation and control plan development.SES, CERTIFICATIONS Preferred Qualifications ISO 13485:2016 Lead Auditor Certification (or willingness to obtain); CQE or CQA preferred. Ability to read engineering drawings, GD&T, and electrical schematics; hands-on experience with electromechanical assembly and inspection Lean manufacturing tools (5S, Kaizen, Statistical Process Control, poka-yoke) and applied statistics (sampling plans, MSA/Gage R&R) Working knowledge of ISO 13485, 21 CFR Part 820, ISO 14971, and applicable product standards (IEC 60601-1, ISO 14708, ISO 10993, IEC 62366) Supplier quality management experience: auditing, corrective action, and quality agreements Strong communicator – able to author clear technical documents and collaborate across R&D, manufacturing, regulatory, and operations Ability to work effectively within fast-paced, cross-functional teams with shifting priorities 8+ years of medical device quality engineering experience, with 3+ years in a manufacturing environment Class III implantable device experience – neuromodulation, vascular, or cardiac rhythm management preferred Experience supporting FDA or Notified Body inspections and/or regulatory submissions Compensation The base salary range for this role is $130,000 – $150,000 depending on experience, skills, and qualifications. In addition to base salary, this role may be eligible for discretionary bonuses and/or equity grants, subject to board approval and company policy. Visa Sponsorship We are unable to offer visa sponsorship for this position at this time. Benefits (for W-2, full-time, exempt employees in the US only) ***Intern positions not eligible Subsidized medical and dental insurance coverage for you and your dependent(s) Life insurance, short-term disability, long-term disability 401k Discretionary unlimited PTO Flexible Spending Account for you and your dependent(s), with eligible plan elections Commuter benefits for NY employees Equal Employment Opportunity (EEO) Synchron is an equal opportunity employer. We are committed to creating an inclusive environment for all employees and applicants and provide equal employment opportunities without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, veteran status, or any other characteristic protected by applicable law. If you need a reasonable accommodation during the application or interview process, please let us know. Join Us At Synchron, you will be part of a transformative mission, and you will work alongside driven people who believe in the power of collaboration and innovation to make a lasting impact. If you are excited to stretch your skills and contribute to something meaningful, apply now and build the future with us.
About Synchron Synchron’s vision is to build non-surgical brain–computer interfaces at global scale that protect the fundamental human rights of freedom of expression and autonomy. Our first mission is to develop motor decoders that restore the ability of 15 million people with paralysis to interact with the digital world. Our second mission is to develop whole-brain cognitive decoders that enable hundreds of millions of people with cognitive decline to preserve and expand their agency as cognition changes over time. In pursuing these goals, we aim not only to help humans flourish, but also to drive fundamental discoveries in human intelligence. Our team operates at the intersection of healthcare and technology, translating breakthrough research into real-world, safety-critical systems. Senior Quality Engineer (New Product Development) Quality Location: San Diego, CA (On-site) Employment Type: Full-Time About the Role As Senior Quality Engineer (New Product Development), you will serve as the Quality lead across Synchron’s product development programs, partnering with R&D, Systems Engineering, Clinical, Regulatory Affairs, Manufacturing Engineering, and Operations to ensure quality is built into products from concept through commercialization. You will lead Design Quality activities, ensure compliance with FDA, ISO 13485, ISO 14971, and applicable international regulations, and facilitate successful transfer of new products into manufacturing. You will also provide operational quality support during pilot builds and early production while contributing to the development and continuous improvement of Synchron’s Quality Management System. Key Responsibilities Design Quality & New Product Development Serve as the Quality representative on cross-functional product development teams from concept through commercialization. Ensure compliance with Design Controls in accordance with FDA 21 CFR Part 820, ISO 13485, and applicable global regulations. Lead Design Quality deliverables including: Design Reviews Design Verification & Validation (V&V) Design History File (DHF) development Traceability Engineering Change Assessments Facilitate product risk management activities in accordance with ISO 14971, including hazard analyses, risk assessments, FMEAs, and verification of risk controls. Review and approve product requirements, specifications, protocols, reports, drawings, and engineering documentation to ensure quality and regulatory compliance. Collaborate with engineering teams to establish critical quality attributes, acceptance criteria, and design inputs/outputs. Drive Design for Manufacturability (DFM), Design for Assembly (DFA), Design for Reliability (DFR), and Design for Quality (DFQ) principles throughout development. Up to 20% travel expected, primarily for contract manufacturer visits and supplier audits. Design Transfer & Manufacturing Readiness Partner with R&D and Manufacturing Engineering to execute successful design transfer into production. Develop manufacturing quality strategies including Process FMEAs, Control Plans, inspection strategies, and manufacturing quality gates. Support process validation activities (IQ/OQ/PQ), equipment qualification, and pilot manufacturing builds. Evaluate manufacturing readiness and identify quality risks prior to product launch. Support engineering changes through impact assessments and change control activities. Operations & Supplier Quality Collaborate with Operations and Supplier Quality to qualify suppliers and contract manufacturers supporting new product development. Review supplier validation activities, incoming inspection strategies, and quality documentation. Support investigations involving nonconforming materials, manufacturing deviations, and CAPAs associated with prototype and pilot production. Monitor quality metrics during new product introduction (NPI) and drive continuous improvement initiatives. Quality Systems & Regulatory Support Author and maintain Design Quality documentation including: Design Plans DHFs Risk Management Files SOPs Quality Plans Verification & Validation protocols and reports Support Regulatory Affairs during submissions by ensuring quality documentation is complete and inspection-ready. Participate in internal audits, supplier audits, FDA inspections, and Notified Body audits. Contribute to continuous improvement of Synchron’s Quality Management System. Required Qualifications Bachelor’s degree in mechanical engineering, Biomedical Engineering, Electrical Engineering, or a related technical/science field 7+ years of Quality Engineering experience in an FDA-regulated medical device environment with demonstrated experience supporting new product development, design controls, risk management, verification & validation, and design transfer. Experience supporting Class III medical devices preferred. CERTIFICATIONS Preferred Qualifications ISO 13485:2016 Lead Auditor Certification (or willingness to obtain); CQE or CQA preferred. Demonstrated knowledge of FDA Design Controls and product development processes. Strong understanding of ISO 13485, ISO 14971, FDA 21 CFR Part 820, and applicable product standards. Experience with Design Verification, Validation, Design Reviews, Design History Files, and traceability. Experience performing Design and Process FMEAs and applying risk management principles. Knowledge of process validation (IQ/OQ/PQ), manufacturing process development, and design transfer. Familiarity with supplier quality management and contract manufacturing. Ability to interpret engineering drawings, GD&T, and product specifications. Strong technical writing and documentation skills. Excellent communication and collaboration skills within multidisciplinary development teams. Ability to balance innovation with regulatory compliance in a fast-paced product development environment. Compensation The base salary range for this role is $130,000 – $150,000 depending on experience, skills, and qualifications. In addition to base salary, this role may be eligible for discretionary bonuses and/or equity grants, subject to board approval and company policy. Visa Sponsorship We are unable to offer visa sponsorship for this position currently. Benefits (for W-2, full-time, exempt employees in the US only) ***Intern positions not eligible Subsidized medical and dental insurance coverage for you and your dependent(s) Life insurance, short-term disability, long-term disability 401k Discretionary unlimited PTO Flexible Spending Account for you and your dependent(s), with eligible plan elections Commuter benefits for NY employees Equal Employment Opportunity (EEO) Synchron is an equal opportunity employer. We are committed to creating an inclusive environment for all employees and applicants and provide equal employment opportunities without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, veteran status, or any other characteristic protected by applicable law. If you need a reasonable accommodation during the application or interview process, please let us know. Join Us At Synchron, you will be part of a transformative mission, and you will work alongside driven people who believe in the power of collaboration and innovation to make a lasting impact. If you are excited to stretch your skills and contribute to something meaningful, apply now and build the future with us.
WHO ARE WE Sonaca North America is driven by a passion for innovation and a commitment to excellence. As a leading provider of aerospace and defense solutions, we are dedicated to making air and space travel safe and sustainable. We have 11 locations across North America and our engineering expertise and operational excellence set us apart from the competition. Since the beginning in 1948, we have a proven track record of delivering high-quality products and services that are reliable, safe, and efficient. Our team of experts is dedicated to staying ahead of the curve in the aerospace and defense industry, utilizing the latest technologies and processes to ensure that we deliver the best possible solutions to our customers. POSITION SUMMARY We are currently seeking a Quality Manager . This position is responsible to lead the total plant Quality Assurance / Quality Control system. This includes all traditional quality verification activities including receiving and in-process inspection; test, audit, and repair activities; continuous improvement; product launch; supplier quality; and quality system compliance. Our Quality Managers plan, coordinate and direct the facility quality control program the design of which ensures continuous production of products consistent with established standards by performing the following duties personally or through subordinates. Acts as focal for inter plant communication and plan development, assuring a cohesive Sonaca North America approach to meeting its and its customers’ quality system requirements. ESSENTIAL JOB RESPONSIBILITIES Ensure that processes needed for the Quality Management System (QMS) are established, implemented and maintained. Ensure the promotion of awareness of customer requirements throughout the organization. Develop, collect, and report performance metrics as needed to senior management including defect and scrap data including corrective action status. Provides budgetary inputs for training and ongoing quality assurance activities to meet near and long-term contract requirements. Establishing systems for data collection and analysis then using that data to drive continuous improvement activities. Lead and monitor CAR (Corrective Action Request) and Root Cause Corrective Action (RCCA) activities for systemic issues and to ensure robust product and process improvements. Plan, lead and measure process and voice of customer performance and quality system effectiveness and adjust in strategy and/or procedures as necessary. Lead proactive quality improvements through the proper execution of Advanced Product Quality Planning (APQP) within the facility to ensure the flawless launch of new products and managing quality deliverables associated with product and process design changes. Through familiarity with customer requirements, analyzes existing quality procedures and systems to determine their level of compliance to requirements. Develops or enlists the support of others to develop revisions to procedures or formulate new procedures, including delineation of areas of responsibility and technical instructions. Oversees inspections of raw materials, materials in process, and finished products. Responsible for the development of quality standards and protocols for quality assurance testing models. Formulates quality control objectives for the facility, e.g. defect reduction and operator certification for specified quality tasks and coordinates the objectives with production management and manufacturing procedures to maximize product reliability and minimize costs associated with rework, scrap and escapements. Communicates expectations of performance and results, coach’s individuals and team toward achievement and holds them accountable for performance, using both positive reinforcement and disciplinary action as necessary and within the confines of fairness and company policy. Works to develop and facilitate a cohesive team environment which builds confidence and strong morale among inspection personnel and between inspection and manufacturing and support personnel. Trains and directs the activities of QC personnel engaged in the inspection and testing of work-in-process and finished products to insure continuous control of materials and products, consistency in the interpretation of quality requirements, inspection methods and the calibration and use of various inspection media; consistency in the completion of quality documentation (including manufacturing work orders, NMD's, first article and customer specific quality paperwork). Ensures that QC personnel devote a significant proportion of their time and effort in the orientation and training of manufacturing personnel to recognize product quality, interpret customer engineering and related requirements, understand inspection methods and use appropriate inspection media in the proper way to evaluate part configuration. Ensure that all new staff are inducted into the requirements of the QMS related to their own roles and responsibilities. Provide update training as necessary. Investigates and responds to customer complaints regarding quality. This may entail technical responses to written claims and complaints, on-site visits to customer facilities, negotiation with customer quality representatives and/or reporting process capability and out-of-scope issues to interested customer service and program management personnel. Develops a cooperative, professional relationship with manufacturing management in order to facilitate and coordinate functions and operations between the departments and to establish responsibilities, procedures and criteria for attaining quality and manufacturing objectives. Evaluates constraints of the existing quality department processes and procedures and develops strategies to address and resolve the constraints (e.g. source backlog, variability in inspection criteria/interpretation, random auditing, sampling) and monitors backlog of future work in order to adjust staffing requirements by moving existing personnel or adding personnel as appropriate. Develops or assists with the development of training and workshops to ensure that personnel are informed and knowledgeable about Sonaca North America quality system and procedures. Responsible to ensure that training resources are maintained in accordance with established procedure and that individual and group training records are forwarded to the appropriate person(s) for input into database and hard copy files. Ensure that document control procedures are utilized to approve, review and update all changes to critical documents within the scope of the QMS. Manage, coach, and develop the quality team and promote a positive quality culture throughout the facility by establishing sound systems and a demonstrated process focus. Carries out personnel management responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. EDUCATION AND EXPERIENCES Minimum 7 years' experience in Quality Assurance working in a progressively responsible capacity, minimum of 3 years in a supervisory capacity. Bachelor’s degree in Engineering, preferably Aerospace, Mechanical or Industrial Engineering Experience as a Quality Assurance Manager in technical industry Experience in recognized quality (ISO9001/AS9100) and process (NADCAP) systems in an aerospace and/or defense environment Experience implementing ISO 9001/AS9100 and other quality initiatives Working knowledge of mechanical inspection methods and tools including ability to read and understand manufacturing routers, instructions, and drawings including GD&T Experience with training and building strong work teams that require minimal management oversight using good delegation skills and understand participative decision-making. Experience with 6 Sigma an advantage, but not essential Trained quality systems auditor highly preferred Pay range for this role is - $125-$135k Physical Requirements While performing the duties of this job, the employee is frequently exposed to moving mechanical parts and fumes or airborne particles. The employee is occasionally exposed to toxic or caustic chemicals and outside weather conditions. The noise level in the work environment can vary from moderate to high. Ability to sit or stand for extended periods of time Noise levels ranging from quiet to extremely loud Required to wear Personal Protective Equipment (PPE) when working on the manufacturing floor including, but not limited to, eye, ear, and foot protection May occasionally lift and /or move up to 10-50 pounds WHY CHOOSE SONACA NORTH AMERICA? We take care of our people. 401(k) retirement savings plan with a percentage company-match contribution Competitive wages Paid holidays Paid time off Medical, dental, vision, life, and accidental insurance Short-term disability Long-term disability Employee assistance plan — for access to counseling, consulting and other community resources Wellness program Tuition assistance Subject to eligibility, terms, and conditions This job description is only a summary of the typical functions of the job, not an exhaustive or comprehensive list of all possible job responsibilities, tasks, and duties. The responsibilities, tasks, and duties may differ from those outlined in the job description and other duties, as assigned, may be required. This document does not create an employment contract. Employees of the Company are employed on an “at will” basis and may be terminated at any time. Sonaca North America is an equal employment opportunity employer. Consistent with applicable law, Sonaca North America provides access and opportunities to those with disabilities. This includes providing reasonable accommodation to individuals with disabilities and disabled veterans who seek to access the company’s online application system. If an applicant is unable to fully access the online application system, Sonaca North America will provide a reasonable accommodation. Applicants with disabilities may contact us at 636-916-2400 for assistance accessing the on-line application system. Callers should have a detailed description of the requested accommodation, their name and preferred method of contact ready for Sonaca North America‘s Human Resources Department. Sonaca North America will make every effort to respond within two (2) business days. This phone number is not for the general submission of application materials. Sonaca North America is an E-Verify Employer. Sonaca North America is an Equal Employment Opportunity /Disability/Veterans Employer NOTICE ON FRAUDULENT JOB OFFERS It has been brought to our attention that there have been instances of fraudulent job offers, purporting to be from Sonaca North America and/or its affiliates (“LMI Aerospace”). This type of fraud is normally carried out through online services such as false websites, or through fake e-mails or call from people claiming to be from the company. These persons offer fraudulent employment opportunities to applicants and often ask for sensitive personal and financial information. The fraudsters may also request recipients to provide personal information and/or to make payments as part of their fake recruiting process. Sonaca North America d oes not ask for any financial commitments from candidates as a pre-employment requirement and will always require candidates to formally apply for positions via the Careers Page or job postings. Sonaca North America has no responsibility for fraudulent offers and if you believe you have been a victim of a fraudulent job offer concerning Sonaca North America, please email [email protected] . Work Location: In person
Company Description ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients’ lives by Overcoming Resistance In Cancer. ORIC’s clinical stage product candidates include (1) rinzimetostat (ORIC-944), an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (2) enozertinib, a brain penetrant inhibitor that selectively targets EGFR exon 20, HER2 exon 20 and EGFR atypical mutations, being developed across multiple genetically defined cancers. Beyond these two product candidates, ORIC® is also developing multiple precision medicines targeting other hallmark cancer resistance mechanisms. ORIC has offices in South San Francisco and San Diego, California. For more information, please go to www.oricpharma.com, and follow us on X or LinkedIn. Reporting to the Quality Assurance Manager, the Quality Assurance Associate will support Technical Operations activities, providing review and disposition of manufacturing and testing records. The successful candidate will work closely with Quality Assurance, Technical Operations, and third-party Contract organizations. Job Description Support Quality Assurance (QA) Batch Record Review, Product Disposition in the review and assessment GMP manufacturing and testing records ensuring all records are complete, accurate and compliant prior to product disposition. Collaborate closely with Technical Operations and/or third-party contract organizations to resolve any documentation discrepancies identified during review. Support GMP investigation processes by assisting in gathering information and data to the responsible investigators conducting root cause analysis, assessing product impact and identifying corrective and preventive actions in accordance with written Standard Operating Procedures (SOPs). Organize review and support activities to ensure timely review and disposition of materials and/or product to meet manufacturing and clinical program timelines. Participate in cross functional program meetings to provide appropriate QA updates. Maintain and update GMP controlled batch tracking tools, documentation files and folders in accordance with written SOPs. Facilitate GMP training for internal departments as required. Identify and facilitate continuous improvement of internal Policies, SOPs and Work Instructions, as needed. Support internal audits and regulatory inspections, as needed. Perform all duties in keeping with ORIC’s core values, policies and all applicable regulations. Qualifications Bachelor’s or Master’s degree in Life Sciences, or a related discipline 0-3 years of relevant experience in Quality Assurance or 1-2 years of relevant laboratory experience in an academic or regulated environment. Knowledge of GMP regulations and guidance documents is preferred, including but not limited to: 21 CFR Parts 11, 210, 211 Applicable ICH Quality Guidelines for Good Manufacturing Practices (GMP) EU EudraLex Volume 4 Experience with electronic quality management systems such as Veeva or MasterControl is a plus. Demonstrated ability to work independently and efficiently in a collaborative, fast-paced, integrated, multidisciplinary team environment that includes external partners. Proven ability to manage multiple priorities and deliver high-quality work. Demonstrated initiative, ownership, problem identification, problem solving, and analytical and strategic thinking skills. Demonstrated ability to quickly adapt and find creative solutions to ensure deliverables are met. Excellent verbal and written communication skills Additional Information The anticipated salary range for candidates who will work on-site at our San Diego location is between $60,000-$85,000 for Associate level. The final wage offered to a successful candidate will be dependent on several factors that may include, title, type and length of experience within the role, type and length of experience within the industry, education, geography, and other job-related factors. ORIC Pharmaceuticals, Inc. is an equal opportunity employer. ORIC does not discriminate based on race, color, religion, gender, sexual orientation, gender identity, age, national origin, disability status, protected veteran status, or any other legally protected characteristics.
Sr. Engineering Project Manager .buttontext2321358db7e7bf1e a{ border: 1px solid transparent; } .buttontext2321358db7e7bf1e a: focus{ border: 1px dashed #004080 !important; outline: none !important; } Bachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. With over 50 years of experience and expertise Bachem provides products for research, clinical development and commercial application to pharmaceutical and biotechnology companies worldwide and offers a comprehensive range of services. Bachem operates internationally with headquarters in Switzerland and locations in Europe, the US and Asia. The company is listed on the SIX Swiss Exchange. For further information, see www.bachem.com. A brief overview The Sr. Engineering Project Manager leads the implementation of large‑scale production processes and equipment at Bachem, applying best‑practice project management methodologies to capital projects. This role oversees system start‑up activities and ensures that engineers and operations staff are fully trained to operate and troubleshoot new equipment effectively. What you will do Transfer Bachem proprietary manufacturing technology from Bachem Switzerland to Bachem America. Leverage engineering design principles and large‑scale production technologies used in Bachem Switzerland to guide equipment implementation and ensure alignment with global standards. Implement and build manufacturing infrastructure to mirror Bachem Switzerland utilizing experience gained in Bachem to maximize capabilities Lead cross-functional teams (Quality, Production, Facilities, Engineering) within a matrix environment Oversee CapEx projects for new GMP laboratories and equipment (AHU, dehumidifiers, chillers, etc.), cleanrooms and lyophilizers, as well as controls and automation associated with these activities Develop and train employees on the utilization of maintenance schedules for new equipment Support the Engineering Director on capital projects for facility remodeling and expansion Perform activities associated with the design and qualifications of the new and existing equipment used in a manufacturing plant Create new process and equipment drawings based on specifications and standards Act as the lead project manager for the design and construction of new plant expansions and plat-related capital projects Work with other departments, contractors, and vendors Perform process development studies for new and existing projects. Write summary reports to support the process development data. Write standard operation procedures, standard test procedures, master batch records and other related GMP documents Qualifications Master’s degree in engineering, science, business or related field with 5+ years of relevant work experience Bachelor’s degree in engineering, science, business or related field with 10+ years of relevant work experience Associate’s degree in engineering, science, business or related field with 15+ years of relevant work experience Minimum of 8 years pharm/biotech experience Work experience in GMP-related capital projects Knowledge of cGMP, pharmaceutical manufacturing methods and engineering principles Technical knowledge of processes, equipment, and utilities (batch processing, tank, filtration, lyophilization, purified water systems etc.) Experience with peptides (preferred) General lab instrument (GC, FTIR, NMR and KF) knowledge and operation experience (preferred) PMP certification (preferred) Strong MS Suite skills, particularly MS Project, Sharepoint, etc. Excellent written and oral communication skills Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment Ability to lead engineering teams in project management practices and assist engineering manager in developing site-wide procedures regarding managing capital projects Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues Strong interpersonal skills to influence and negotiate with Bachem functional managers Communicate effectively and ability to function well in a team environment Plan projects from inception to completion. Ability to maintain a live-up-to-date risk register, schedule, budget and issues log related to program/project activity. Base salary range: $126,317 - $173,686 Placement of new hires in this wage range is based on several factors including education, skill sets, experience, and training. Total Rewards We offer all Team Members a total rewards package including competitive pay, annual performance bonus, a generous benefit package with comprehensive Medical/Dental/Vision coverage, 401(k) plan with employer contribution, and paid vacation, personal and sick days. Corporate Social Responsibility Bachem takes responsibility for future generations by a careful handling of resources and avoiding environmental risks. We continually improve our ecological performance and develop and implement new approaches for enhancing employees’ environmental awareness. EcoVadis has awarded Bachem Gold Medal status in their assessment of Bachem. Bachem Americas is an Equal Opportunity Employer As an equal opportunity employer, we celebrate the diversity of our team and are committed to building an inclusive workplace where individuals are hired and advanced based on merit, skills, and qualifications. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or other legally protected status. .buttontext71be19411ba8c841 a{ border: 1px solid transparent; } .buttontext71be19411ba8c841 a: focus{ border: 1px dashed #004080 !important; outline: none !important; } At Bachem, you’ll find a diverse, multicultural team. The (a) in the job title stands for all. We welcome applications from all candidates. What matters are your skills and motivation—regardless of age, gender, background, religion, or sexual orientation. Please note: unsolicited resumes from recruitment agencies will not be considered. .right-align { text-align: right; } Nearest Major Market: San Diego
Company: IPS Group, Inc. is a design, engineering and manufacturing company focused on wireless telecommunications and parking technologies. IPS manufactures its products locally and has been delivering world-class solutions to the telecommunications and parking industries for over 25 years. The company is best known for its patented credit card-enabled, solar powered parking meter and web-based management system. Job Description We are currently seeking a reliable, hard-working technician/fabricator for our expanding operation. In this role, you will be a part of our metal fabrication team, ensuring our production goals are met in a realistic time frame while adhering to standards for safety and quality. You will need to be punctual, able to perform repetitive physical tasks, and lift 65 lbs. unassisted. Machine Shop Tech II is responsible for performing various tasks to set up, operate, monitor, and troubleshoot production machines/equipment. Will also be responsible for inspecting parts to specifications, making machine adjustments and tool changes to maintain quality specifications. Machine Shop Tech II utilizes specialized machines and tools on a day-to-day basis to complete advanced fabrication/manufacturing projects. This is a group environment where team cooperation is a required skill. Essential Duties and Responsibilities Demonstrate professionalism Follow all written and verbal instructions Adhere to safe work practices and guidelines Attend all safety and production trainings Work cooperatively with production team(s) Ensure production standards are maintained Perform necessary tasks for proper equipment startup and shutdown Operate machinery/ tools/ devices with caution and care Alternate operation of multiple types of equipment day-to-day for quality production and minimal unplanned stops Fabrication and manufacturing projects involving engineering drawings Utilization of specialized tools and equipment Metal finishing (using power tools to deburr and shape production parts as needed) Participation in daily department cleanup Maintain a safe and organized work area Maintain general hygiene and sanitation standards Qualifications and Skills High school diploma or equivalent required Math, reading, writing, verbal communication skills Capable of reading and understanding production documents and safety manuals Understanding of industry technology, including specialized tools/equipment Previous experience working in industry Comply with all safety guidelines (non-negotiable) Physically capable of manual labor (lifting, bending, reaching, ) Able to lift 65 unassisted Able to stand for 8 hours (with breaks) Position Type/Expected Hours of Work This is a full-time position. Hours of work are Monday through Friday, 7:00 a.m. to 3:30 p.m., 40 hours per week. Other Duties Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities are subject to change. Work Environment The work environment described here is representative of those that an employee encounters while performing the essential functions of this job. Reasonable accommodation may be provided to enable individuals with qualified disabilities to perform the essential functions. The position is in the factory and involves sitting, standing, walking, lifting, manipulating materials for long periods of time throughout the day in an indoor environment that is organized and typically free of hazardous materials. Note: The above statements are not intended as an exhaustive list of all responsibilities, duties and skills required of personnel in this classification. Nothing in the job description restricts IPS Group, Inc. from the right to change, assign, or reassign duties and responsibilities at any time for any reason. Furthermore, they do not establish a contract for employment as this is an "At-Will Employer." It is the policy of IPS Group, Inc. not to discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, sexual orientation, or veteran status. Benefits: 401(k) 401(k) matching Dental insurance Health insurance Life insurance Paid time off Vision insurance Job Type: Full-time Salary range: $22 - $27/hr. An Equal Opportunity Employer—M/F/D/V
Salary Range: $93,000 - $101,000 POSITION SUMMARY The Quality Engineer is responsible for driving process excellence and executing strategic quality initiatives. Reporting directly to the Quality Director, this role does not manage people but serves as the ultimate champion and owner of quality processes. The ideal candidate acts as a cross-functional conduit of quality—collaborating with co-manufacturers (co-mans), vendors, and internal teams during plant trials, managing non-conformances, and ensuring audit readiness. ESSENTIAL FUNCTIONS Reasonable Accommodations Statement To accomplish this job successfully, an individual must be able to perform, with or without reasonable accommodation, each essential function satisfactorily. Reasonable accommodations may be made to help enable qualified individuals with disabilities to perform the essential functions. Essential Function Statements Deviation Management: Review, investigate, and assess planned and unplanned process deviations; partner with teams to identify true root causes and implement robust corrective and preventive actions (CAPAs). Supplier Quality Investigations & SCARs: Issue, manage, and execute Supplier Corrective Action Reports (SCARs) for co-manufacturers and raw material/packaging vendors; perform diligent follow-ups to ensure timely containment, resolution, and compliance. Non-Conformance Tracking: Monitor, investigate, and follow up on Non-Conformance Reports (NCRs) from inception to final disposition, ensuring defective materials or products are properly segregated and tracked. SOP Training: Develop training materials and conduct regular employee training on Standard Operating Procedures (SOPs) to guarantee plant-wide alignment with regulatory guidelines and internal quality benchmarks. Plant & Packaging Trials: Serve as the on-the-floor quality conduit during plant trials and new packaging trials; provide real-time quality oversight, evaluate process capabilities, and document findings to ensure seamless scaling. Should be involved in new equipment or process validation in collaboration with R&D and Manufacturing Engineering counterparts. Audit Representation: Actively participate in, prepare documentation for, and support internal, third- party, and regulatory quality audits. Initiative Execution: Assist the Quality Director in rolling out corporate quality initiatives, continuous improvement projects, and data-driven quality programs across the organization. POSITION QUALIFICATIONS Competency Statement(s) Problem Solving & Root Cause Analysis: Proficient in structured problem-solving methodologies (e.g., 5 Whys, Fishbone diagrams, 8D) to resolve complex process issues. 7/2/26 Process Ownership & Autonomy: Demonstrated ability to manage, monitor, and optimize complex quality processes independently without requiring direct oversight of personnel. Collaboration & Influence: Exceptional interpersonal skills to act as a collaborative partner and quality conduit between internal operations, co-manufacturers, and external vendors. Detail-Oriented & Compliance-Driven: Uncompromising focus on documentation accuracy, regulatory standards, and meticulous record-keeping. Project Management: Ability to prioritize multiple moving parts—such as simultaneous plant trials, open NCRs, and supplier follow-ups—while meeting critical deadlines. SKILLS & ABILITIES Education: Bachelor's degree in Engineering, Quality Management, Food Science, Chemistry, or a related technical discipline is required. ASQ Certified Quality Engineer (CQE) or equivalent quality certification is highly desirable. Experience : 3–5 years of direct experience in a quality engineering or quality assurance role within a manufacturing environment. Proven experience working within regulated industries (e.g., dietary supplements, food manufacturing, pharmaceuticals, or medical devices). Hands-on experience managing vendor relationships, co-manufacturers, and executing SCAR/NCR workflows. Computer Skills: High proficiency with Quality Management Systems (QMS) and Enterprise Resource Planning (ERP) software (e.g., SAP). Advanced knowledge of Microsoft Office Suite (particularly Excel for data tracking, Word for SOP drafting, and PowerPoint for training delivery
How will you make an impact? The Lead Manufacturing Technician, based in San Clemente, CA will be responsible for the completion of the scheduled production and management of preventative maintenance. The Lead will ensure proper documentation (cGMP and GDP), open/close jobs in MRP system, and provide feedback and updates to Management and Engineering. This position will also prepare components, build assemblies, and bulk drug formulations. All activities will be performed with good documentation practices (GDP) in accordance with current good manufacturing practices (cGMPs) and quality system regulation (QSR) medical device good manufacturing practices (GMP) requirements. Additional tasks will include performing the following: Filing, capping, and crimping operations Packaging and labeling operations Sampling Visual inspections Documentation and data input into materials requirement planning (MRP), Batch Records (BRs), and Device History Record (DHR) Track clean room, environmental chambers, and equipment preventive maintenance (PMs) What will you do? Manage the operation schedule, project schedule, and adjusts the schedule and resources accordingly Supervise production technician(s) to optimize quality and output Ability to perform all activities outlined for a Manufacturing Technician as needed Verify all documentation is followed and completed accurately (cGMP, QSR, and GDP) Manages Oracle to open and close jobs Manages inventory requests and reconciliation for accuracy Revise documentation to ensure accuracy and compliance Communicate feedback to engineering on Non-Standard Build Requests, Validation builds, Clinical builds, etc. How will you get here? To be successful in this role, you will need to have the following: Industry (medical device, pharmaceutical, and/or biotechnology) and educational experience. 8 – 10 years’ experience with high school diploma 6 – 8 years’ experience with associate degree in science or engineering 4 - 6 years’ experience with bachelor’s degree in science or engineering It is highly desirable to have experience working in and maintaining a clean room in accordance with GDP, cGMPs, and QSR standards. #GKOSUS Generous. Innovative. Leadership-driven. Family-oriented. Socially responsible. Founded in 1998, Glaukos Corporation is an ophthalmic pharmaceutical and medical technology company focused on developing and commercializing novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases. Our mission at Glaukos is to truly transform vision by pioneering novel, dropless therapies that can meaningfully advance the standard of care and improve the lives of patients suffering from chronic, sight-threatening eye diseases. Innovation is at the core of everything we do, and we are resolute in our commitment to challenge conventional thinking with new treatment alternatives that are supported by real science, robust clinical evidence, and an unrelenting focus on patients. Our constant pursuit of game-changing technologies that disrupt legacy treatment paradigms is encapsulated in the Glaukos mantra “We’ll Go First,” which articulates our willingness to take chances, our determination to forge new ground, and our commitment to continuous improvement in all that we do. Our company completed an initial public offering in June of 2015, and our shares are traded on the New York Stock Exchange under the ticker symbol “GKOS”. Our global headquarters is in Aliso Viejo, California with additional locations in San Clemente, California, and Burlington, Massachusetts. Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law. All offers of employment are contingent upon the successful completion of a background check, including successfully passing a drug screen, based on the position and local regulations.