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2 weeks ago

QA Operations Specialist

Novartis - Carlsbad, CA

Summary About this role: Our QA Operations Specialist manages Quality aspects and projects within area of responsibility as well as ensuring and supporting overall GxP conformity and Compliance with the Novartis Quality Management Systems for the Indianapolis manufacturing site. Location: Carlsbad, CA #LI-Onsite Shift: This position involves shift work which will be defined through site start up and commercialization readiness. About the Role Key Responsibilities: Provide QA support of production, QC, engineering, and supply chain operations through review/approval of test records for batch release, SOPs, CAPAs, Deviations, OOX investigations, Quality Risk Assessments, Quality Plans/Events, protocols, and change controls. Additionally, provide shop floor oversight with QA/compliance guidance to support decision-making throughout these processes. Manufacturing support includes live batch record review and execution of AQL inspections. Support continuous quality improvement initiatives for manufacturing operations by collaborating with production, QC, engineering, and supply chain teams to implement and optimize processes that enhance efficiency. Support all regulatory inspections by assisting with preparedness initiatives and executing inspection activities, while also continuously performing/supporting any tasks necessary to ensure product quality and maintain site cGMP compliance as needed. Provide cGMP and associated OJT training to any other quality members and other operational areas as needed. Cross Train Expectations: QA Batch Release: Perform Master Batch Record approvals and issuance of batch records and labels Perform Raw Materials release, updating statuses of materials in the ERP system. Reviewing and approving raw material documentation and supplier CoAs to ensure quality and compliance of raw materials to be used in manufacturing processes. Perform Final Batch Record Review and Final Product Release Perform a comprehensive review of all executed batch records and associated documentation to ensure compliance with specifications and regulatory requirements before product release. QA Compliance: Support the following programs as needed: Change Control Management, Customer Complaint Management, Document Control Management, Training Program Management, Supplier Qualification Program, Audit/Self-Inspection Program, Annual Product Quality Review (APQR), Logbook Issuance Essential Requirements Education: Bachelors' Degree, preferably in Life Sciences, Chemistry or related relevant degree strongly preferred 2+ years of experience in a GxP (Bio)pharmaceutical or API manufacturing operations 1+ years of experience in a quality assurance role Collaborating across boundaries Functional Breadth QA and/or QC experience in pharmaceutical industry with environmental monitoring & cleanliness zones Knowledge of FDA and EU regulations and experience in US and international regulatory agency inspections. The salary for this position is expected to range between $81,200 and $150,800/year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Division Operations Business Unit Innovative Medicines Location USA State California Site Carlsbad Company / Legal Entity U469 (FCRS = US469) AAA USA Inc. Functional Area Quality Job Type Full time Employment Type Regular Shift Work No

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2 weeks ago

Manufacturing Engineer

General Atomics - San Diego, CA

GA’s Electromagnetic Systems (EMS) Group focuses on the military and commercial applications of advanced electromagnetic technologies, including power generation and distribution, magnetic levitation, laser and weapons systems, and systems design and engineering. The EMS Group supports government customers, which include the Department of Defense, Department of Energy, the Department of Transportation as well as a range of commercial customers. Under general supervision, this position supports the manufacturing production process with focus on the design, development, and implementation of new or revised production processes for the efficient and economical fabrication of parts, components, sub-assemblies, and final assemblies. DUTIES AND RESPONSIBILITIES: Develops, implements, and maintains methods, operation sequence and processes in the manufacture or fabrication of parts, components, sub- assemblies, and final assemblies. Conducts tests throughout all stages of production to determine control over applicable variables and troubleshooting and resolving manufacturing problems of moderate scope and complexity. Designs the sequence of production operations, specifying procedures for the fabrication of applicable tools and equipment, and adapting machinery. Collaborates with product design engineering on technical specifications that will best utilize equipment and manufacturing techniques. Estimates manufacturing costs and determines time standards. Ensures that production processes and procedures are in compliance with regulations. Maintains records and reporting systems for coordination of manufacturing operations. Develops appropriate documentation of findings and implemented solutions and communicates results to staff. Maintains the strict confidentiality of sensitive information. Performs other duties as assigned. Responsible for observing all laws, regulations and other applicable obligations wherever and whenever business is conducted on behalf of the Company. Expected to work in a safe manner in accordance with established operating procedures and practices. We recognize and appreciate the value and contributions of individuals with diverse backgrounds and experiences and welcome all qualified individuals to apply. 50907 Job Qualifications: Typically requires a bachelors in engineering or a related technical field as well as two or more years of manufacturing engineering experience. May substitute equivalent experience in lieu of education. Electrical/Mechanical background is preferred. Must have a general understanding of manufacturing engineering concepts, principles, and theory with technical experience demonstrating the application of those concepts while ensuring safety and regulatory compliance. Must possess the ability to understand new concepts quickly and apply them accurately throughout an evolving environment and organize work assignments to meet established timetables. Good communication, computer, documentation, presentation, and interpersonal skills are required, as well as the ability to work both independently and as part of a team. Experience in Microsoft Visio, Project and Excel are highly preferred. Experience with SAE 9100 is preferred. Experience with SOLIDWORKS, CREO and SAP preferred. Must be able to work extended hours as required. Must be able to work both independently and on a team. Salary:$68,770 - $116,193Travel Percentage Required 0 - 25Relocation Assistance Provided Not Provided US Citizenship Required? YesClearance Required? No Clearance LevelEntry-Level (0-2 years) WorkstyleOnsite

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2 weeks ago

Dental Manufacturing Manager

Dental Metrics Maven - San Diego, CA 92122

Job Title: Senior Manufacturing Manager – Dental Operations. Location: San Diego, CA. Compensation: $140,000 – $150,000 base salary. Bonus: Up to 15% annual performance bonus. Relocation Assistance: Available for the right candidate. About the Company: A growing, innovative dental manufacturing company based in San Diego is seeking a Senior Manufacturing Manager to lead its subtractive and additive operations. This is a key leadership role within a fast-paced environment, focused on delivering high-quality dental products and driving continuous improvement across production teams. The position offers long-term growth potential and succession planning into executive leadership. Position Overview: The Senior Manufacturing Manager will oversee all aspects of production across both subtractive (milling) and additive (3D printing) workflows. You’ll manage a team of approximately 25 employees and be responsible for maintaining operational excellence, developing team members, and implementing lean manufacturing practices. This role reports directly to the Vice President of Manufacturing, with the opportunity to grow into their successor role. Key Responsibilities: Lead day-to-day operations in a high-volume, dental manufacturing facility. Oversee team performance, staffing, training, and workflow optimization. Implement and maintain lean manufacturing processes and continuous improvement strategies. Foster a positive and efficient workplace culture, handling employee relations as needed. Ensure compliance with regulatory and quality standards related to dental and medical manufacturing. Partner cross-functionally with other departments to align production with company objectives. Contribute to long-term planning and strategic development of manufacturing operations. Required Qualifications: Minimum 10 years of experience in dental manufacturing. At least 7 years of experience in a leadership or management role overseeing production teams. Proven ability to manage teams of 20+ employees in a hands-on manufacturing environment. Strong knowledge of lean manufacturing principles; certification preferred. Experience with both subtractive (milling) and additive (3D printing) processes. Excellent people leadership skills with a track record of building cohesive teams. Must be authorized to work in the U.S. without current or future visa sponsorship. Preferred Qualifications: Experience in dental device manufacturing regulated by 21 CFR Part 820 or other medical standards. Familiarity with quality management systems and internal/external audit processes. Background in managing multi-shift or expanding operations. Bachelor’s degree in engineering, business, or a related technical field (or equivalent experience). Additional Information: The ideal candidate is hands-on, results-driven, and capable of stepping into a future executive role. Company culture is fast-paced, direct, and performance-focused. The leadership team values clarity, accountability, and initiative. This is a newly created role due to growth—not a replacement. To Apply: Please submit your resume and a brief cover letter outlining your qualifications and interest in the role.

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2 weeks ago

Manufacturing Associate 1

Werfen - San Diego, CA 92131

Job Information Number ICIMS-2025-9271 Job function Manufacturing Job type Full-time Location San Diego - AID - 9900 Old Grove Road San Diego, California 92131-1638 United States Country United States Shift 1st About the Position Introduction Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care. Overview Job Summary Werfen Autoimmunity Manufacturing Associates play a critical role in the manufacturing and/or testing of a variety of Autoimmune-related diagnostics products. This position is responsible for the manufacture and/or testing of components of diagnostic kits used by clinicians around the world for the diagnosis of autoimmune disorders. Our Manufacturing Associates work in a highly specialized team environment, using advanced automated equipment and instrumentation to manufacture and test in-process components and raw materials. Employees help ensure product quality by participating in troubleshooting and developing quality improvements within our multiple value streams. Work is performed under department supervision and in accordance with the company’s Quality Management System. Employees working in the ELISA team manufacture ELISA plates, calibrators and controls, and all other related components. Employees working in the IFA team manufacture IFA slides, controls, bulks and all other related components. Employees working in the QUANTA Flash and Aptiva team manufacture coupled beads, calibrators, controls, and all other related components. Employees working in the Product Testing team test products from all product lines (ELISA, IFA, QUANTA Flash, and Aptiva) and all other related components. Employees working in the Biotechnologies Manufacturing team manufacture raw materials for use in the manufacturing processes for all product lines (ELISA, IFA, QUANTA Flash, and Aptiva). Responsibilities Key Accountabilities Under supervision follows standard operating procedures, work instructions, and other pro-cedures for routine manufacturing and/or testing. Participates in the bulking and/or evaluation of in-process components and reagents ac-cording to procedures. Packages, fills, and operates equipment to ensure in-process components are completed (if applicable). Maintains detailed Device History Records and/or any other associated documentation for all manufacturing activities. Operates and cleans equipment and instrumentation for routine manufacturing and/or test-ing. Assists with evaluations of raw materials (if applicable). Follows established safety and environmental procedures. Maintains lab and work area in a clean and orderly manner. Complies with applicable Werfen standard operating procedures (SOPs), ISO, FDA and other Quality System regulations, as well as applicable Environmental Health & Safety (EHS), Human Resources and other regulatory and company policies. Reflects Werfen Values in the quality of work and in working relationships. Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions. Qualifications Minimum Knowledge and Experience: Education: Bachelor’s degree in biologicial or related sciences required. Certificate program or A.S. degree with 3-4 years relevant experience in a life sciences laboratory may be substitued for a degree. Experience: 0-1 years of life sciences laboratory experience required. Experience in a regulated manufacturing environment in the healthcare sector strongly preferred. Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement. Skills & Capabilities Basic understanding of basic laboratory practices and procedures. Basic understanding of Good Manufacturing Practices. Strong attention to detail and commitment to quality. Attentiveness to details to spot flaws in products or problems with equipment to prevent quality issues. Problem-solving ability to troubleshoot and resolve issues. Time management skills to meet production goals without compromising quality. Ability to work collaboratively in a team environment. Curiosity and commitment to continuous learning. Work EnvironmentThe physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to communicate. Must be able to detect, identify and inspect scientific data. The employee will be required to stand and/or walk up to 8 hours per day and/or sit for up to 8 hours per day. Must be able to use hands to feel objects, including keyboard, telephone and pipettes or other lab equipment. May need to reach with hands and arms, climb stairs, balance, stoop, kneel or crouch. Will be required to talk and hear and have specific vision abilities, including close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. May occasionally have to lift and/or move up to 25 pounds. The noise level in the work environment will vary but is usually moderate. This position is very active and requires varying levels of mobility. Salary range for this position is $25-$29/hr If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV. Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact [email protected] for assistance. We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team. www.werfen.com

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2 weeks ago

Mechanical Engineer Lead – Li-ion Battery Pouch Cell Assembly

American Lithium Energy Corporation - Carlsbad, CA 92008

We are seeking a highly skilled Mechanical Engineer Lead to oversee the design, optimization, and operation of lithium-ion battery pouch cell assembly processes. This role will be responsible for leading mechanical engineering activities, developing assembly equipment and fixtures, and ensuring high-quality, safe, and efficient production. The ideal candidate will have deep expertise in pouch cell manufacturing, mechanical systems design, and cross-functional project leadership.. *Duties and responsibilities* * Lead Engineering Efforts: Direct mechanical engineering activities related to pouch cell assembly, including process design, tooling, and equipment integration. * Process Development: Design and optimize assembly processes such as stacking, electrode alignment, electrolyte filling, formation, sealing, and packaging. * Equipment Design & Integration: Develop specifications, review vendor equipment, and lead validation of pouch cell assembly lines. * Quality & Reliability: Collaborate with quality engineers to define mechanical tolerances, failure modes, and root cause analysis for process improvements. * Team Leadership: Mentor junior engineers and technicians, ensuring best practices and technical excellence. * Collaboration: Work closely with R&D, manufacturing, and supply chain teams to transition new cell designs from prototype to mass production. * Continuous Improvement: Implement lean manufacturing principles and advanced process controls to improve yield, throughput, and product quality. * Safety & Compliance: Ensure equipment and processes meet applicable safety, environmental, and regulatory standards. * Perform other duties as assigned. *Qualifications* * Bachelor’s or master’s degree in mechanical engineering, Manufacturing Engineering, or related field * 7+ years in mechanical engineering with at least 3 years in Li-ion battery pouch cell manufacturing. * Proven experience leading engineering teams in a high-tech manufacturing environment. * Hands-on and responsible * Excellent oral and written communication skills * Driven to complete tasks on time with minimal supervision. * Demonstrates a high degree of initiative and motivation with a willingness to work independently or on a team. *Physical requirements* * Capable of standing and walking for extended periods. * Must able to wear PPE at work when required * Must be ok to work in the environment with Li-ion battery production * Must be able to bend, squat, reach, and climb on a frequent basis. * Must be able to lift, pull and push up to 50lbs. Job Type: Full-time Pay: From $40.00 per hour Benefits: * 401(k) * 401(k) matching * Dental insurance * Flexible spending account * Health insurance * Health savings account * Life insurance * Paid time off * Vision insurance Ability to Commute: * Carlsbad, CA 92008 (Required) Ability to Relocate: * Carlsbad, CA 92008: Relocate before starting work (Required) Work Location: In person

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2 weeks ago

Process Technician – 1st Shift (Onsite)

Pratt & Whitney - Carlsbad, CA 92008

Date Posted: 2025-08-21 Country: United States of America Location: PW192: Carlsbad 5940 Darwin Court , Carlsbad, CA, 92008 USA Position Role Type: Onsite U.S. Citizen, U.S. Person, or Immigration Status Requirements: U.S. citizenship is required, as only U.S. citizens are authorized to access information under this program/contract. Security Clearance: None/Not Required Pratt & Whitney is working to once again transform the future of flight—designing, building and servicing engines unlike any the world has ever seen. And because transformation begins from within, we’re seeking the people to drive it. So, calling all curious. Come ready to explore and you’ll find a place where your talent takes flight—beyond the borders of title, a country or your comfort zone. Bring your passion and commitment and we’ll welcome you into a tight-knit team that takes our mission personally. Channel your drive to make a difference into shaping an organization and an industry that’s evolving fast to the future. At Pratt & Whitney, the difference you make is on display every day. Just look up. Are you ready to go beyond? What You Will Do: The Process Technician is responsible for operating and maintaining industrial systems, including vacuum furnaces and gas control systems, to ensure efficient production processes. This role involves monitoring processes, performing regular maintenance, mechanical assembly, and supporting experimental designs to improve operations. The technician will work primarily onsite during the first shift, contributing to the manufacturing of advanced aerospace components. Operate industrial systems including vacuum furnaces, vacuum pumps, gas control systems, and pollution control equipment Load production systems with numerous parts per documented configuration Perform regular maintenance on systems. Perform mechanical assembly tasks according to engineering drawings, blueprints, and specifications. Monitor processes while running, including attending to alarms and diagnosing issues for resolution or escalation Support experimental designs to improve the process Program equipment to adjust settings for new processes Provide support in the development and implementation of facility and equipment upgrades Maintain all documentation (electronic and paper) required for the production process Comply with AS9100 quality system including SOPs (standard operating procedures), internal requirements, manufacturer's specifications, and safety policies May perform other duties as assigned Qualifications You Must Have: Typically requires HS diploma (or equivalent, e.g. G.E.D in the US) with a minimum of 2 years of relevant experience U.S. citizenship is required, as only U.S. citizens are authorized to access information under this program/contract Must have proficient computer experience with MS Office Qualifications We Prefer: AA/AS degree or other 2-year post high school training with a minimum of 4 years of relevant experience Manufacturing background Previous aerospace or chemical industry experience is preferred Experience working within a formal quality system like ISO 9001 AS9100 Demonstrated mechanical and technical aptitude and experience Forklift, cranes and other material handling equipment. What We Offer: Medical, dental, vision benefits Life, short term disability, long term disability benefits Paid time off including vacation, sick leave, holidays 401-K with company match Other innovative benefits including deals and discounts Learn More & Apply Now! In addition to transforming the future of flight, we are also transforming how and where we work. We’ve introduced role types to help you understand how you will operate in our blended work environment. This role is: Onsite: Employees who are working in Onsite roles will work primarily onsite. This includes all production and maintenance workers, as they are essential to the development of our engines. Candidates will learn more about role type and current site status throughout the recruiting process. For onsite and hybrid roles, commuting to and from the assigned site is the employee’s personal responsibility. The salary range for this role is $22.40 - $42.01 per hour; however, Raytheon Technologies considers several factors when extending an offer, including but not limited to, the role and associated responsibilities, a candidate’s work experience, location, education/training, and key skills. Hired applicants may be eligible for benefits, including but not limited to, medical, dental, vision, life insurance, short-term disability, long-term disability, 401(k) match, flexible spending accounts, flexible work schedules, employee assistance program, Employee Scholar Program, parental leave, paid time off, and holidays. Specific benefits are dependent upon the specific business unit as well as whether or not the position is covered by a collective-bargaining agreement. Hired applicants may be eligible for annual short-term and/or long-term incentive compensation programs depending on the level of the position and whether or not it is covered by a collective-bargaining agreement. Payments under these annual programs are not guaranteed and are dependent upon a variety of factors including, but not limited to, individual performance, business unit performance, and/or the company’s performance. This role is a U.S.-based role. If the successful candidate resides in a U.S. territory, the appropriate pay structure and benefits will apply. RTX anticipates the application window closing approximately 40 days from the date the notice was posted. However, factors such as candidate flow and business necessity may require RTX to shorten or extend the application window. RTX is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or veteran status, or any other applicable state or federal protected class. RTX provides affirmative action in employment for qualified Individuals with a Disability and Protected Veterans in compliance with Section 503 of the Rehabilitation Act and the Vietnam Era Veterans’ Readjustment Assistance Act. Privacy Policy and Terms: Click on this link to read the Policy and Terms

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2 weeks ago

Manufacturing Manager

Surface Optics Corporation - San Diego, CA 92127

Summary: Direct single-site manufacturing operations through a team of functional engineers, technicians and administrators. Ensure increasing levels of customer and employee satisfaction while improving the efficiency of manpower, materials and machines. Manage all aspects of production planning, scheduling and budgeting. Champion continuous improvement efforts and defect reduction initiatives to establish an effective Quality Assurance management system. Implement quality improvement activities as appropriate to raise the performance of the company product lines. Educate and train employees as to their impact in the quality assurance management system. Duties and Responsibilities include the following. Other duties may be assigned. Responsible for the management of policy deployment in the areas of Lean manufacturing techniques, quality, cost reduction, complete and on-time delivery, safety, customer satisfaction, employee relations, visual controls and plant performance measures.* Provide leadership for employee relations through effective communications, coaching, training, and development. Provide leadership for problem resolution to facilitate fast improvements and improved working relationships. Implement and manage a fully functional supply chain management/production control infrastructure. Manage material requirements to increase inventory turns and reduce levels on hand. Ensure compliance with Company standards for cost control, waste reduction, quality, OSHA, safety. Responsible for completion and on-time delivery at the lowest possible cost and highest quality. Balance work cell capacity/loading across the manufacturing department. Review and optimize manufacturing personnel weekly scheduling and output, update capacity plans for business and sales plan inputs Interface with other departments to communicate and upstream operations and receive and address feedback regarding manufacturing issues affecting downstream departments. Provide Estimated Time to Complete (ETC) for products and input on quotes Lead negotiations with suppliers to take advantage of discounts and price breaks Implement and manage company procedures for quality process control, process improvement, testing, and inspection. Mandatory attendance at all-hands meetings including SOC safety, security and HR.

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2 weeks ago

Machine Operator – 1st, 2nd & 3rd shifts

Moore & Associates - San Diego, CA 92128

Leading medical device components manufacturer has several openings for Production Laser Machine Operators. Operates automated Laser CNC machinery and related equipment to fabricate precision metal parts by performing the following duties. ESSENTIAL RESPONSIBILITIES: * Reads and interprets blueprints to maintain dimensions within tolerances of precision machined parts. * Reads and interprets Process Sheets to ensure parts are manufactured in accordance with standard processing requirements. * Maintains machine specific tools and consumables to ensure effective operation of equipment * Ensures high quality of parts by closely monitoring and adjusting operation of machine and/or tooling while regularly inspecting parts for conformance to requirements. * Ability to quickly detect minor malfunctions or out-of-tolerance machining. * Performs secondary bench operations as required, which includes but is not limited to inspection, harperization, de-burring, and cleaning of parts. * Maintains lot traceability, work orders/travelers, and good housekeeping practices at all times. * Quickly raises any machining or quality issues with appropriate supervision or engineering support. * Ability to learn and work on a wide variety of part numbers and/or departments. * Maintain daily production goals consistently * Able to run multiple machines at a time * Work overtime and weekends as needed QUALIFICATIONS/ KNOWLEDGE/ EXPERIENCE (TECHNICAL/ PROFESSIONAL KNOWLEDGE & SKILLS COMPETENCY) * High school diploma or equivalent and/or vocational training preferred * 1-2 years of CNC type machining work experience with demonstrated ability or related technical certificate program. * Ability to operate CNC type machines at a high level of precision daily, and utilize microscope, Nikon, and other related equipment with optimal accuracy. * Ability to use in process inspection tools. * Ability to occasionally lift 10 – 20 pounds. * Employee stands, sits and walks frequently. * Frequently required to reach and grasp with both hands and arms and occasionally stoop, kneel, or crouch. Frequent fine hand manipulation * Specific vision abilities required by this job include close vision, peripheral vision, depth perception, and the ability to adjust focus Shifts Available: 1st Shift: 5:30 am - 2:00 pm (1 opening) Pay: *$21.50/hr* 2nd Shift: 1:30 pm - 10:00 pm (2 openings) Pay: $21.50 + 10% shift diff = *$23.65* 3rd Shift: 9:30 pm - 6:00 am (1 opening) Pay: $21.50 + 20% shift diff = *$25.80/hr* Job Type: Full-time Pay: $21.50 - $25.80 per hour Benefits: * Health insurance Work Location: In person

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2 weeks ago

Production Lead

Kelcourt Plastics - San Clemente, CA 92673

Support in supervising, managing, and coordinating the work activities of the production team to ensure efficient processing of work orders following quality standards. Adhere to our safety policy, follow the Safety Absolutes, and promote safety at all times. Maintain and promote Spectrum's standards of conduct at all times. Uphold and promote the vision and core values of Spectrum Plastics Group. Work closely with the Production Manager to follow production schedules and manage the production process. Assign daily work tasks to team members according to the production schedule and ensure that production orders meet quality and lead-time requirements. Support the production team of operators and packers using practical management of extrusion machines and packaging processes. Ensure that employees adhere to established procedures and product quality standards and drive continuous improvements on the shop floor. Review, control, and maintain records of scrap, line efficiencies, and quality of production orders daily. Work as a team with other production groups. Anticipate and determine the causes of production delays and take appropriate action to meet production deadlines. Manage labor needs and schedules to ensure production runs smoothly while verifying that hours worked are accurately recorded in the system. Ensures all production employees are properly trained and submit all appropriate training documentation to HR. Ensures employee growth and development and the ability to meet Spectrum Plastics Group performance standards. Treats all employees with respect and reports any anomalies detected within their group or any other group. Ensures all emails are responded to in a timely manner and that meetings are confirmed to ensure projects are completed on time. Uses Paycom software to make changes to employee timecards and approve vacation time. Perform other duties as needed and as specified by the management team. Attend all supervisory meetings, either in person or by phone. (Attendance at meetings is required to communicate announcements and discuss team performance.) Compliance with all SPG policies and Code of Conduct standards. Responsible for understanding and complying with all SPG and Dupont safety policies and procedures. Responsible for recognizing and reporting safety hazards and early reporting of work-related pain/injury. The employer retains the right to change or assign other duties to this position. • Experience in a related field. • Ability to use MS Office and work in ERP systems. • Previous experience in the plastics industry is preferred. • Strong mechanical aptitude. • Ability to troubleshoot and resolve issues. • Ability to apply knowledge to daily job functions using pre-established guidelines and instructions in a constantly changing production environment. • Accuracy, diligence, attention to detail, and thoroughness. • Computer proficiency. • Proficient communication skills in both English and Spanish. • Ability to understand and comply with company safety and quality standards. • Ability to follow oral and written instructions. • Background in medical devices is preferred. • 10 years of experience directly related to equipment supervision.

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2 weeks ago

Manufacturing Technician I, Production Support

- San Diego, CA 92121

SUMMARY Under supervision, the Manufacturing Technician, Production Support, will perform routine manufacturing activities in GMP manufacturing areas, solution preparation, dispensing raw material, bioprocessing support and autoclave operation. Operations will be performed according to Standard Operating Procedures (SOP), Work Instructions (WI) and Master Batch Records (MBR). Perform manufacturing steps, execute routine MBRs, and revise documents such as MBRs and SOPs as needed. Flexible shift schedules and overtime may be required. JOB RESPONSIBILITIES Perform GMP manufacturing activities in assigned areas. Perform routine cleaning activities in GMP manufacturing areas Follow Standard Operating Procedures (SOPs), cGMPs, plant safety guidelines and other established procedures during the manufacturing process to produce quality products. Set-up, operate, maintain and clean bioprocessing equipment. Demonstrate good aseptic technique. Perform dispensing raw material. Basic troubleshooting of bioprocess equipment. Perform manual cleaning and sterilization of parts and components. Accurately complete and maintain detail-oriented process-related documentation of equipment logs and batch records following the good manufacturing documentation practices. Draft and revise SOPs and batch records. Address production issues and report any compliance related concerns to the supervisor. JOB REQUIREMENTS Education and Experience High School Diploma, Bachelor's or advanced degree in life sciences or related discipline, or equivalent education and experience. High school diploma with 3 or more years of experience in the pharmaceutical or biotech industry Bachelor's degree with 0-3 years of experience in the pharmaceutical or biotech industry, or equivalent education and experience. Knowledge, Skills and Abilities: cGMP manufacturing for biological products is preferred. Fundamental knowledge of current biologics regulations and cGMP for drug substance operation. Proficient with Microsoft Word and Excel. Able to work with pressurized systems, steam, and corrosive chemicals with necessary safety precautions. Demonstrated ability to follow and document activities in written procedures and/or logbooks. Detail oriented, strong team player. Effective collaboration skills and the ability to work cross functionally across categories and internal stakeholders.

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2 weeks ago

Assembler Tester I, 2nd Shift (2:30 pm – 11:00 pm)

HME - Carlsbad, CA 92010

HME has been creating innovative products for the drive-thru and pro-audio industries since 1971. From the very beginning, we've known these solutions would never have happened without the customer-focused people who make up our company. HME has a team environment with a culture of collaboration, learning, and growth. With subsidiaries located in California, Missouri, Canada, UK, India, and China, companies around the world depend on HME for clear, reliable communication solutions. From setting the standard for drive-thru headsets and timer systems in the quick service restaurant (QSR) industry to developing professional audio equipment used in the Olympic Games, HME strives to create the newest, most innovative products on the market while providing quality care and attention to its customers. Come join our team! Come write your chapter of the HME story. Are you good with your hands? Do assembly instructions make sense to you? Are you looking to start a new career and not just another job? HME is actively recruiting candidates with great Attitudes and Aptitude for an entry-level position as an Assembler Tester I, 2nd shift. In this position, you will train for and perform various electromechanical assembly, test, and inspection procedures. This is a great introduction to a rewarding technical career. Not only will you gain technical skills, but you will also have the opportunity to complete additional career development trainings to pursue your career goals. This is a 2nd shift position working 2:30 pm - 11:00 pm Monday-Friday. What you will do in the position: Assemble, rework, and reassemble product as specified on applicable documentation Verify accuracy of instruction documents Check work for accuracy, quality, and conformance to specifications, through verification and testing Work directly with supervisor or lead to advise of work-related problems or product discrepancies Record test data and results What you will need to succeed in this position: Skills to perform moderate-to-complex assembly operations Ability to read and interpret manufacturing drawings and assembly aides Determination to get things done with minimal direction Basic computer skills Good manual dexterity The starting rate is $18.00/hr plus a 10% shift differential for 2nd shift. Our benefits package includes tuition reimbursement; 3 weeks paid vacation your first year, paid holidays, medical, vision, and dental coverage, pet insurance, life insurance, and 401K contributions. The physical demands and work environment 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. The employee will occasionally lift and move up to 50 pounds with assistance. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.

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2 weeks ago

Manufacturing Associate 1

Werfen - San Diego, CA 92131

Overview: Job Summary Werfen Autoimmunity Manufacturing Associates play a critical role in the manufacturing and/or testing of a variety of Autoimmune-related diagnostics products. This position is responsible for the manufacture and/or testing of components of diagnostic kits used by clinicians around the world for the diagnosis of autoimmune disorders. Our Manufacturing Associates work in a highly specialized team environment, using advanced automated equipment and instrumentation to manufacture and test in-process components and raw materials. Employees help ensure product quality by participating in troubleshooting and developing quality improvements within our multiple value streams. Work is performed under department supervision and in accordance with the company’s Quality Management System. Employees working in the ELISA team manufacture ELISA plates, calibrators and controls, and all other related components. Employees working in the IFA team manufacture IFA slides, controls, bulks and all other related components. Employees working in the QUANTA Flash and Aptiva team manufacture coupled beads, calibrators, controls, and all other related components. Employees working in the Product Testing team test products from all product lines (ELISA, IFA, QUANTA Flash, and Aptiva) and all other related components. Employees working in the Biotechnologies Manufacturing team manufacture raw materials for use in the manufacturing processes for all product lines (ELISA, IFA, QUANTA Flash, and Aptiva). Responsibilities: Key Accountabilities Under supervision follows standard operating procedures, work instructions, and other pro-cedures for routine manufacturing and/or testing. Participates in the bulking and/or evaluation of in-process components and reagents ac-cording to procedures. Packages, fills, and operates equipment to ensure in-process components are completed (if applicable). Maintains detailed Device History Records and/or any other associated documentation for all manufacturing activities. Operates and cleans equipment and instrumentation for routine manufacturing and/or test-ing. Assists with evaluations of raw materials (if applicable). Follows established safety and environmental procedures. Maintains lab and work area in a clean and orderly manner. Complies with applicable Werfen standard operating procedures (SOPs), ISO, FDA and other Quality System regulations, as well as applicable Environmental Health & Safety (EHS), Human Resources and other regulatory and company policies. Reflects Werfen Values in the quality of work and in working relationships. Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions. Qualifications: Minimum Knowledge and Experience: Education: Bachelor’s degree in biologicial or related sciences required. Certificate program or A.S. degree with 3-4 years relevant experience in a life sciences laboratory may be substitued for a degree. Experience: 0-1 years of life sciences laboratory experience required. Experience in a regulated manufacturing environment in the healthcare sector strongly preferred. Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement. Skills & Capabilities Basic understanding of basic laboratory practices and procedures. Basic understanding of Good Manufacturing Practices. Strong attention to detail and commitment to quality. Attentiveness to details to spot flaws in products or problems with equipment to prevent quality issues. Problem-solving ability to troubleshoot and resolve issues. Time management skills to meet production goals without compromising quality. Ability to work collaboratively in a team environment. Curiosity and commitment to continuous learning. 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. While performing the duties of this job, the employee is regularly required to communicate. Must be able to detect, identify and inspect scientific data. The employee will be required to stand and/or walk up to 8 hours per day and/or sit for up to 8 hours per day. Must be able to use hands to feel objects, including keyboard, telephone and pipettes or other lab equipment. May need to reach with hands and arms, climb stairs, balance, stoop, kneel or crouch. Will be required to talk and hear and have specific vision abilities, including close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. May occasionally have to lift and/or move up to 25 pounds. The noise level in the work environment will vary but is usually moderate. This position is very active and requires varying levels of mobility. Salary range for this position is $25-$29/hr

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