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*Job Title: Sr. CMC SME (Biotech/Pharma)* *Location: Carlsbad, CA (100% Onsite)* *Duration: 6 months* *Pay Rate: $70/hr - $100/hr (depending on experience)* *Job Description:* * Client's BLA (Biologics License Application) target is early next year. * Need a CMC (Chemistry, Manufacturing & Controls) SME to make sure manufacturing process is set, and BLA can be filed on time. * Need someone with both manufacturing CMC and some regulatory background as well. *Must Have Skills/Experience:* * 15+ years’ experience in CMC * Bringing products to BLA * Viral vector experience *Nice to Have Skills/Experience:* * Gene therapy experience * Process validation experience * Analytical background * Regulatory background *W2 position – only US Citizens, Green Card holders, or candidates with EADs, OPT need apply (no C2C).* Job Type: Contract Pay: $70.00 - $100.00 per hour Expected hours: 40 per week Application Question(s): * Have you been directly involved in bringing products to a Biologics License Application (BLA) submission? * Do you have viral vector experience in a biotech or pharmaceutical environment? * Are you legally authorized to work in the US on a W2 basis (no C2C)? * Do you have gene therapy experience?(Nice to have) * Do you have process validation experience?(Nice to have) Experience: * Chemistry, Manufacturing & Controls (CMC): 10 years (Required) Ability to Relocate: * Carlsbad, CA 92010: Relocate before starting work (Required) Work Location: In person
Under general direction, the Quality Assurance Inspector is responsible for monitoring and auditing the quality of manufactured goods using tools defined by the Quality Management System (QMS), Enterprise Resource Planning (ERP) system and process work instructions/methods. Responsibilities also include programming CMM machines to properly measure product to drawing specifications and standards. This position will participate with continual improvement initiatives and interact with all departments to provide support. Essential Functions: Plan and perform detailed inspections of materials, parts and assemblies using precision measuring equipment. Perform receiving, in-process, final and shipping inspections to ensure quality and conformance to specifications. Conduct First Article Inspections and generate First Article Inspection Reports (FAIR) in accordance with QMS requirements. Document all inspection results per company policies and requirements in the ERP system. Generate and process Non-Conforming Reports. Review and approve non-conformances (NC) and material review board (MRB) dispositions. Review documents and ensure requirements are met. Analyze reports and production data to identify trends and recommended updates to quality standards and procedures when necessary. Initiate correction/preventative action activities for nonconforming product including investigation, follow-up and root cause analysis. Participate in internal quality system audits for AS9100, ISO 13485, ISO 14001 as well as customer audits. Support FPC and defect trending activities as required by quality system. Set-up and run existing CMM programs. Program and calibrate the CMM. Perform and document maintenance as needed. Collaborate with Engineering and Production departments regarding measurement inspection matters. Work cross-functionally as a team to meet production/customer deadlines. Share knowledge and lead training in areas of expertise (i.e. measurement techniques). Support other departments or functions as needed, based on skill set and company priorities, to ensure operational efficiency and team success. Education, Experience, and Skills: To perform this job successfully, an individual must be able to satisfactorily perform each essential function. High School diploma. Minimum of 3 years of experience in quality assurance functions or similar. Experience working in contract manufacturing preferred. CMM set-up, operating and programming capabilities. Previous experience with and understanding of ISO9001, AS9100, ISO13485, ISO14001, AS9102, and FAR – DFAR documentation. Familiarity with quality testing tools and procedures required. Strong English communication skills. Must be able to create and write clear and detailed records and documents. Strong computer skills including Microsoft Office and must be able to perform assigned duties within the ERP system. Ability to work independently, stay focused, and perform in a fast-paced and deadline driven environment. Good analytical and problem solving skills, as well as a keen attention to detail. Strong interpersonal and teamwork skills are necessary to enable individual to work with all positions and personalities. Excellent customer service skills and understanding of building customer relationships. Physical Demands: The physical requirements for this position involve frequently remaining in a stationary position (sitting or standing) and frequently moving throughout all work centers. This position frequently lifts or carries 10lbs or less, occasionally lifts or carries object weighing 11-25lbs, and occasionally lifts 26-50lbs with assistance. This position occasionally reaches over head to move or measure product. This position requires the continuous use of hands/arms to operate a computer and to place and inspect material. This position continuously exchanges information with supervisors and coworkers regarding tasks and product. This position must be able to read drawings and work instructions and perceive color and fine detail. Compensation Range: QA Inspector: $23.00 - $27.00 per hour or D.O.E. What we offer: Medical, Dental, Vision, Voluntary Supplemental Benefits PTO plan with paid end of year shut down Supportive work/life balance culture 401(k) ITAR Requirements: This position requires use of information which is subject to the International Traffic in Arms Regulations (ITAR). All applicants must be U.S. persons within the meaning of ITAR. ITAR defines a U.S. person as a U.S. Citizen, U.S. Permanent Resident (i.e. 'Green Card Holder'), Political Asylee, or Refugee. MEI 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, disability or veteran status.
Position Summary The Production Support Technician supports daily shop operations by preparing and finishing raw materials for production. This role primarily focuses on cutting raw material to specified sizes, buffing, sanding, and etching metal products to meet Reotemp Instruments’ quality standards. Work closely with machinists, welders, and production staff to ensure materials are properly prepared and available for manufacturing. The ideal candidate has the aptitude to learn and operate equipment with growth opportunities within the organization as skills and knowledge increases. Key Responsibilities Cut raw materials (metal bars, tubes, and sheets) to specified dimensions using saws and cutting tools. Perform surface finishing operations, including buffing, sanding, deburring, and polishing. Assist in laser etching of metal components. Organize, stage, and move raw materials and finished parts within the shop. Maintain shop equipment, tools, and work areas in a clean and safe condition. Follow standard operating procedures and safety guidelines. Assist machinists, welders, and production staff with basic tasks as needed. Inspect materials for defects and report quality issues to the supervisor. Qualifications High school diploma or equivalent required. Prior machine shop or metalworking experience preferred but not required. Ability to use hand tools, power tools, and shop equipment safely. Knowledge of basic measuring tools (rulers, calipers, tape measurer, etc.) Strong attention to detail and quality. Physical ability to lift and move metal stock and materials (up to 50 lbs). Willingness to learn and follow directions in a fast-paced shop environment.
Job Description We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows. Job Description Everyone at Kite is grounded by one common goal - curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Would you like to join us in this mission? Seeking a motivated leader with an Operational Excellence (OE) mindset to drive OE initiatives at our cancer immunotherapy viral vector manufacturing site in Oceanside, CA (MVP01). This role is part of the company-wide OE Network and will lead the development and implementation of OE programs across Technical Operations locally and throughout the network. The OE Senior Manager plays a critical role in driving meaningful change by working directly with stakeholders, employees, and processes to embed a culture of excellence through hands on engagement and continuous improvement. The Senior Manager demonstrates experience in applying continuous improvement techniques and producing results for functions, while assessing current business performance against Kite Pharma’s business plan for a specific site and/or function. The Senior Manager partners with cross-functional teams to analyze findings, recommend improvements, and lead strategic continuous improvement initiatives. This role also trains staff and leaders to foster a culture of continuous improvement and reports to the Associate Director of Business Strategy & Operations. Please note: This an onsite role Responsibilities of the Senior Manager of Operational Excellence include: Lead the development and execution of OE strategies to meet site goals, track progress, and escalate risks or barriers to success. Lead and coach teams in Lean methodologies including PDCA, DMAIC, root cause analysis, FMEA, Kaizen, and mistake-proofing. Develop strategic and tactical plans, KPIs, and dashboards to measure and advance MVP01’s OE program. Build and maintain a pipeline of improvement initiatives through strong cross-functional partnerships across Manufacturing, F&E, Quality, Supply Chain, and MSAT. Translate operational requirements into actionable improvement plans, ensuring alignment with site and network goals. Identify and prioritize improvement opportunities by evaluating processes for waste, cost savings, benefit realization, complexity, and inefficiency. Ensure continuous improvement initiatives and site processes apply appropriate Lean/Six Sigma tools, track benefits, and celebrate success to reinforce a culture of excellence. Facilitate Lean leadership behaviors and daily management routines, including visual management and tiered accountability structures. Own and continuously improve the site’s Tiered Meeting Structure, ensuring effective use of SQDEP metrics to drive performance, escalate issues, and foster accountability. Assess when changes are needed to enhance clarity, flow, and impact of tier meetings. Go to the work (Gemba) to observe, engage, and assess operational challenges firsthand, applying Lean principles to identify opportunities for efficiency, flow, and problem-solving. Guide teams in implementing practical solutions that align with OE best practices such as 5S/6S, visual management, and standard work. Conduct Lean Maturity assessments and develop roadmaps for measurable improvement. Serve as a change agent by mentoring leaders and teams, fostering servant leadership, representing the site within the network, and driving adoption of OE principles. Build trust and credibility across all levels of the organization by demonstrating emotional intelligence, active listening, and a collaborative approach to problem-solving. Thrive in a dynamic, fast-paced manufacturing environment by managing multiple priorities, navigating ambiguity, and driving results under pressure. Ensure sustainability of OE initiatives by embedding problem-solving capabilities and Lean thinking into daily operations and team behaviors. Promote knowledge sharing and adoption of best practices across the site and broader manufacturing network. Basic Qualifications: Doctorate OR Master’s degree with 0+ years of Operational Excellence and/or Strategy and/or Operations experience OR Master’s degree with 6+ years of Operational Excellence and/or Strategy and/or Operations experience OR Bachelor’s degree with 8+ years of Operational Excellence and/or Strategy and/or Operations experience OR Associate degree with 10+ years of Operational Excellence and/or Strategy and/or Operations experience OR High School Diploma / GED with 12+ years of Operational Excellence and/or Strategy and/or Operations experience Preferred Qualifications: 6+ years of Operational Excellence process improvement experience in a GMP regulated biotech or pharmaceutical manufacturing environment, ideally involving viral vector production or cell therapy operations. Proven track record of leading Operational Excellence initiatives in a complex manufacturing setting, with measurable impact on throughput, yield, and compliance. Deep understanding of manufacturing processes, quality systems, and regulatory requirements. Lean Six Sigma certification (Black Belt or Kaizen Leader) with demonstrated application of tools such as DMAIC, PDCA, FMEA, and root cause analysis in a manufacturing context. Experience implementing and sustaining Lean Daily Management systems, including tiered accountability, visual management, and standard work in a production environment. Strong facilitation and coaching skills with the ability to train manufacturing teams and leaders in OE methodologies and drive cultural transformation. Ability to navigate between strategic planning and hands-on problem solving. Demonstrated success in leading cross-functional improvement projects involving Manufacturing, F&E, Quality, Supply Chain, and Technical Operations. Proficiency in data analysis and performance tracking using tools such as Excel, Power BI, Smartsheet, and other digital OE platforms. Excellent communication and stakeholder engagement skills, with the ability to influence at all levels of the organization. Proactive and self-directed leader who consistently seeks out improvement opportunities and takes initiative without waiting for direction to implement impactful solutions. The salary range for this position is: $153,935.00 - $199,210.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*. For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. For Current Kite Pharma Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday.
Description: BECOME A GLOBE-TROTTING MACHINIST: SIX-FIGURE INCOME + WORLD TRAVEL! THE ADVENTURE: Get paid to see the world while mastering your craft! As an IPM Field Machinist, you'll be part of an elite team that travels domestically and internationally (up to 75% travel) solving precision machining challenges on-site for clients worldwide. From Laos to Lake Michigan, you may find yourself doing machine repair on top of a wind turbine or the bottom of a ship! Compensation: $100,000+ annually (depending on experience) plus generous travel per diems, overtime opportunities, and performance bonuses! YOUR MISSION (Should You Choose to Accept It) Transform raw materials into precision masterpieces while maintaining tolerances of +/- 0.010. You'll collaborate with a diverse team of machining pros, field experts, engineers, and project leaders to devise the most innovative and cost-effective solutions for our clients. Safety is our superpower – we need you to embody this value every day! Requirements: YOUR ADVENTURE TOOLKIT: Machine Whisperer Skills: Operate manual and field machining equipment like you were born to do it Field Machining Magic: Deploy your talents at client sites around the globe Equipment Mobilization Expertise: Help pack up, move, set up, and maintain our specialized equipment Quality Craftsmanship: Ensure every piece meets exacting standards Problem-Solving Prowess: Provide feedback to continuously improve our processes Dimensional Wizardry: Make measurements with micrometers that would impress NASA THE PERFECT ADVENTURER HAS: High school diploma or GED/HSED (required) – Journeyman or 2-year technical degree (preferred) 5 years' experience with manual and/or field machining Bridgeport knee mill and manual engine lathe expertise Blueprint & mechanical drawing interpretation skills Measurement mastery with various micrometers and inspection tools Basic rigging abilities Knowledge of cutting tools, materials, speeds & feeds Problem-solving abilities in fast-paced environments Ability to lift 50 lbs. and operate power tools PERKS OF THE JOURNEY: TRAVEL THE WORLD SIX-FIGURE INCOME POTENTIAL that rewards your expertise Develop skills with specialized equipment and techniques Variety – no two days or projects are ever the same Continuous learning and career growth opportunities Generous benefits, PTO, and 11 paid holidays REQUIRED ADVENTURES & CERTIFICATIONS: OSHA 10 certification Valid driver's license (required) IPM Overhead Crane Training certification Forklift Training & valid license Availability for travel (including some weekends) Tech-savvy enough to use mobile apps for expenses, time tracking, etc. In-Place Machining provides Equal Opportunity in Employment regardless of race, color, religion, gender, age, national origin, military status, veteran status, disability, sexual orientation, gender identity, genetic information, or any other protected characteristic. Ready to upgrade your career, income, and passport stamps collection? Apply today and begin your machining adventure around the world!
Introduction The Manufacturing Engineer will provide manufacturability oversite during the design phase thru new product introduction and serve as the “eyes of the customer” before we introduce new technologies and designs to our customers. Role and Responsibilities The Manufacturing Engineer in EUV designs, develops implements, and maintains methods, operation sequence and processes in the manufacture, fabrication, testing and troubleshooting of parts, components, sub-assemblies, ensuring Design for Manufacturability and Assembly, final assemblies and systems as well as system hardware and software interface and system controls. Evaluates prototype and manufacturing practices to develop optimized process flows to ensure repeatability and quality Partners with design engineering during prototype, piloting, final product and tooling design reviews to ensure manufacturability, quality, and reliability Writes requirements documents and serves as advocate in design process for Design for Assembly/Design for Manufacturability principals Responsible for introduction of new product into Pilot Manufacturing phase and transition to sustaining engineering Leads and/or participates as a member of cross-functional and cross-site teams. Drives and tracks project progress and updates database to meet defined schedule Develop and improve processes using LEAN/Six Sigma principals Collects issues identified by technicians to define improvement areas. Utilizes structured problem solving for root cause analysis, corrective actions, and solution implementation Participate in design and process FMEA Transfer knowledge to volume factory responsible for executing builds and qualification Validates build/test sequence and material allocations. Write and validate assembly and test processes and procedures to be used in manufacturing. Evaluates and analyzes data acquired during tests. Makes recommendations for process or design modifications based on analysis. Performs failure analysis, uses data for product industrialization changes Serves as a mentor to less experienced team members on root cause analysis and problem solving methodologies and statistical analysis/process control Performs other duties as assigned Education and experience Bachelor’s degree or masters in Electrical Engineering, Industrial, Manufacturing or Mechanical Engineering. Previous internship experience with ASML is a plus. Minimum of two (2) years of experience is preferred in Process Engineering, Industrial Engineering or Manufacturing Engineering. Prior Lithography experience preferred Advanced experience using one or more of the following software packages: Excel, Word, MS Project. Experience with MRP system; SAP preferred LEAN Six Sigma Black Belt Preferred Systems engineering and interaction experience – hardware and software interface Some software, controls experience preferred Experience in executing improvement projects with LEAN Manufacturing concepts. Ability to analyze and translate data to effectively report problems through written and/or graphical formats Ability to multi-task and set priorities without jeopardizing project schedule Data driven decision maker, good negotiation skills, positive attitude Able to read technical drawings and interpret specifications. Able to define Bill of Material structure in support of defined build sequence. Excellent customer service skills, with an advanced understanding of customer relationship and network building. Partner with peer organizations as member of multi-disciplinary teams. Skills Must be comfortable with a rapidly changing work environment. Excellent written, verbal communication and presentation skills Customer service and focus Stake holder management Energetic and enthusiastic Multitasking, priority setting and risk management Team focused but individually accountable Hands on and desire to be the Subject Matter Expert In depth knowledge of MS Word, Excel, PowerPoint. Familiarity with MS Project preferred 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 including working while fully gowned in a clean room environment. The employee may occasionally lift and/or move up to 20 pounds. The employee may be required to travel based on business needs. 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 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. Extended periods of time in a clean room environment should be expected. Requires gowning in Class 10K gowning protocol May need to work in labs with equipment that emit high-pitched noise. May spend extended periods of time at a computer workstation The current base annual hourly range for this role is currently: $30.65-51.08 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. Diversity and inclusion 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 diversity and inclusion 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.
Become part of a team that champions wellness worldwide. CAPTEK® Softgel International is a global leader in the development and production of high-quality nutraceutical supplements. As a contract manufacturer organization (CMO), we collaborate with innovators from some of the world’s most successful brands. Summary: Quality Assurance Manager is responsible for the whole oversight of the Quality Assurance, and floor quality at both manufacturing and packaging sites. They are to appropriate, delegate, and review Quality Assurance operations and related tasks to ensure company's full Quality Assurance support as well as quality operational guidance and training to subordinate staff and other departments within the organization. They will need to ensure the quality assurance group in properly evaluating floor process quality systems and controls, investigations and dispositions, and any other quality needs to drive to quality product manufacture, processes, and systems. The individual will need to continually review and uphold company policies, procedures, and quality requirements required in the dietary supplement industry. Essential Duties and Responsibilities: • Manages all QA Supervisors, Assistant Supervisors, Leads, Technicians, and Document Control Specialists in both manufacturing and packaging facilities. This may include, but is not limited to, scheduling and coordinating work assignments for the department/shifts, along with planning and setting QA department goals and objectives, and respectively coordinating and directing QA department activities. • Per compliance to cGMP, Captek SOPs, and training, thoroughly reviews and verifies Quality Assurance systems and operations within the department and in application at floor, driving facilities' organizational quality. • Conduct departmental adherence, task, and/or job performance reviews which include developing and managing metrics to track and drive facilities' quality performance, respective appropriate actions for negative trend remediation, and for continual improvement. • Represents Captek's Quality Assurance operations as needed in customer and regulatory audits, meetings, qualifications, subsequent CAPA’s and/or any other such required instances. • As necessary, thoroughly reviews completed and/or prepared Quality Assurance documentation and dispositions or endorses appropriately upon verification of documentation as accurate, true, and complete. • Authors and/or reviews Quality Assurance related SOPS, while ensuring proper adherence to by subordinate Quality Control staff. • Perform and/or coordinate training of department personnel as needed, while developing, interpreting, and implementing policies and procedures for the area of responsibility. • Leads cross-functional teams on projects as pertaining to quality and process control initiatives, investigations, policies and/or procedures writing/review, best practices, and/or corrective and preventative action plans. • Assist QA Supervisors for interviewing and hiring QA personnel. • Analyze quality data and make recommendations for improvement, participating in development, interpretation, and implementation of policies and procedures for the area of responsibility. • Initiate disciplinary actions and investigates incidents when required, as appropriate. • Maintains a strong conceptual understanding of the processes, procedures, and quality requirements required of our operations. Provides staff with respective guidance and support. • Assures facilities' compliance with quality requirements, exemplifying adherence to all safety, cGMP, and Captek's Standard Operating Procedures and Policies, particularly, while keeping accountability of staff to the same. • Manages all Captek sites on the use of electronic QMS systems (QCB/MasterControl). • Adhere to HACCP and Food Safety. • Must have the ability to be flexible, handle and support multiple projects simultaneously and adjust personal style to adapt to increased business pressures, and work well under pressure while performing all tasks in an accurate, complete, timely, and appropriate manner. • Must have the ability to communicate effectively inter-and intra- departmentally on matters as pertaining to QA. • Perform other related quality and compliance duties as assigned Vice President of Quality, Regulatory Affairs & Technical Services. Qualifications: • Minimum of 10 years relevant work experience with 5 years in a Supervisory and/or Managerial role • Experience managing and scheduling a shift of five (5) or more employees • Experience in training personnel. Education/Experience: • Minimum Bachelor's degree in health science or related discipline. Master's degree preferred. Equivalent combination of education, experience, background, and assessed aptitude and capacity. • Deep working knowledge of cGMPs and FDA regulations. • ASQ CQA, PCQI and/or CHA certification preferred. Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing 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 is occasionally exposed to work near moving mechanical parts; fumes, or airborne particles and risk of electrical shock. The noise level in the work environment is usually moderate. Physical Demands: 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. Physical demands require sitting for extended periods of time, walking, bending, reaching, carrying, and occasionally lifting and/or moving objects up to 25 pounds. Specific vision abilities required by this job include Close vision, Peripheral vision, and the ability to adjust focus. While performing the duties of this job, the employee is occasionally required to use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and talk or hear. CAPTEK is an equal employment opportunity employer. In order to provide equal opportunities to all individuals, employment decisions will be based on merit, qualifications, and abilities, not on any mental or physical disability. We comply with the law regarding reasonable accommodation for disabled employees and applicants. We do not discriminate on the basis of actual or perceived race, color, national origin, ancestry, sex (which includes pregnancy, childbirth, breastfeeding and medical conditions related to pregnancy, childbirth or breastfeeding), reproductive health decisions, gender, gender identity, gender expression, religious creed, disability (mental and physical) including HIV and AIDS, medical condition (cancer and genetic characteristics ), genetic information, age, marital status, sexual orientation, military and veteran status, or any other characteristic protected by federal, state or local law. Our management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities and general treatment during employment. Thank you for your interest in joining the CAPTEK team. You will be contacted shortly if your application is selected.
About Us: For more than six decades, the skilled thinkers, makers, and doers at Frontgrade have embraced our mission to solve complex technology challenges across the U.S. and around the globe. We’re the leading provider of high reliability and radiation assured solutions for defense, space, intelligence, commercial, and civil applications, and our products are designed to perform in the harshest of environments. From human spaceflight and space exploration to missile defense, electronic warfare, and healthcare tech advancements, our talented team stays in lockstep with our customers to ensure the success of their missions. Do you want to help shape the future? In an environment where innovation and ideas go hand-in-hand? Then come join the Frontgrade Team! Why Work For Us We take care of our people and provide competitive health, wealth and wellbeing benefits – from day one. You’ll also discover learning and development opportunities so you can take your career to the next level – and beyond. Other benefits include: Competitive Benefits: Medical (FSA + HSA), Dental, and Vision Immediate 401K Vesting/Matching Career Opportunity and Growth Tuition Reimbursement Student Loan Repayment Generous PTO and 11 paid Holidays per year (8 regular and 3 floating) 8 weeks of 100% Paid Family Leave *Profit Sharing Plan applies to all non-Annual Incentive Plan and non-Sales Incentive Plan employees. Summary: Performs the set-up, calibration, testing, and troubleshooting of circuits, components, instruments, and mechanical assemblies. Determines and may develop test specifications, methods, and procedures from blueprints, drawings, and diagrams. May complete rework on assemblies and/or systems as a result of testing. Responsibilities: KEY RESPONSIBILITIES Work in production environment to perform testing and troubleshooting of various components Some manual assembly operations are required as part of the test function Carefully follow production documentation and processes, including keeping detailed records of testing and rework performed Work closely with engineering to solve production problems, including setting up and performing complex manual testing. Work on NPI and existing product qualifications. Works from a variety of documents including test specifications, wiring diagrams, schematics, etc. where complete information is frequently lacking or from general oral engineering instructions requiring technical judgment, initiative and experience Complies with standard test procedures and specifications to perform tests on highly complex electronic developmental and production components, subassemblies and systems Verifies and analyzes test results; troubleshoots, repairs and adjusts equipment so that their performance complies with test requirements and that the quality of the product is assured, and determines when rework is necessary to ensure product compliance with specifications Proactively influence plans to establish and maintain necessary test infrastructure to ensure testing is performed in a sustainable and reliable manner Qualifications: QUALIFICATIONS & EXPERIENCE No experience is required in area of responsibility. Ability to obtain and/or maintain a Security Clearance High School Diploma or GED ADDITIONAL INFORMATION This position requires access to technology, materials, software or hardware that is controlled by either ITAR or EAR U.S. export laws. As a condition to this job offer, in order to be employed in this position, you must be able to obtain an U.S. Government export license(s), as required by law. Pay Range: $19.02 - $22.84 hourly. Applicable pay within the posted range may vary based on factors including, but not limited to, geographical location, job function of the position, education, and experience of the successful candidate. Employment Transparency: WE ARE AN EQUAL OPPORTUNITY EMPLOYER We welcome differences and celebrate new ideas. We believe the diversity of our people inspires our creativity and drives our innovation. Everyone is welcome here, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, or genetic information. We are committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation due to a disability for any part of the employment process, please email [email protected]. If you have relevant skills that are not reflected in your resume, we welcome your application and encourage you to share more in an optional cover letter or to join our Talent Community Connect Portal - Connect (icims.com).
Why work for PCI Pharma Services? At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how. Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Job Details: We are looking for a Drug Product Manufacturing Associate I - Formulations who is responsible for the implementation of routine production and manufacturing procedures to support processes and ensure compliance with regulatory requirements. The Associate I will work with the Drug Product team to ensure the successful completion of various cGMP activities. The Associate I will develop a strong understanding of both the technical aspects of the role as well as the quality systems that govern cGMP manufacturing. Responsibilities: Performs various manufacturing tasks, including sterile filtration, formulation, in-process testing, preparation of formulation components, and product development projects, in accordance with established Standard Operations Procedures (SOPs) and cGMP regulations. Supports the implementation of manufacturing procedures and production schedules. Effectively assists other personnel with technical issues and problems that may arise during the shift. Initiates revisions to current Master Batch Records, SOPs, and department desktop aids. Supports the maintenance of group production resources and assists with product development projects. Expected to operate production equipment, including the TFF system, Rotavap, Microfluidizer, Homogenizer, chiller, rotary lobe pump, high shear mixer, SIP, autoclave, depyrogenation oven, and CIP system. Maintains qualification to execute aseptic operations in GMP production facilities comprised of Grade A, B, C, and D manufacturing clean room areas. Supports routine maintenance and troubleshooting of production equipment. Accurately documents, completes, and reviews batch records, as needed. Coordinates and leads preparation of materials and components for sterilization in autoclave or dehydrogenation oven. Collaborates with other technical personnel on troubleshooting and engineering activities. Collects and disposes of lab waste according to established Safety, Health, and Environment (SHE) procedures. Maintains cGMP environment according to the production needs of the Drug Product group. May be required to interact and collaborate with clients and third-party vendors. Works closely with Production Planner to manage QAD work orders and ensure production materials are obtained according to the manufacturing schedule. Regular and reliable attendance on a full-time basis [or in accordance with posted schedule]. Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices. Embodies PCI Pharma Service’s cultural values and aligns daily actions with department goals and company culture. Requirements: High School Diploma required. Bachelor’s degree in a life sciences discipline or equivalent preferred. Minimum of zero to two (0-2) years of relevant experience in a manufacturing or laboratory environment. Detail oriented with strong written and verbal communication skills. Ability to work independently, within prescribed guidelines, or as a team member. Demonstrated ability to follow detailed directions in a manufacturing GMP environment. Familiarity with cGMP, manufacturing, machine operations, and data entry. Must be familiar with Microsoft Office applications. The base hourly range for this position is $21.69 to $24.40 plus annual performance bonus eligibility. Final offer amounts are determined by multiple factors including and not limited to specific and relevant experience, credentials, geography and subject matter expertise. Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future For Los Angeles applicants, we abide by the Fair Chance Initiative for Hiring. Learn more about the policy here: FCIHO Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture. #LI-KC1 Equal Opportunity Employer 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.
Why work for PCI Pharma Services? At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how. Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Job Details: We are looking for a Drug Product Manufacturing Associate I - Formulations - 2nd Shift who is responsible for the implementation of routine production and manufacturing procedures to support processes and ensure compliance with regulatory requirements. The Associate I will work with the Drug Product team to ensure the successful completion of various cGMP activities. The Associate I will develop a strong understanding of both the technical aspects of the role as well as the quality systems that govern cGMP manufacturing. Responsibilities: Performs various manufacturing tasks, including sterile filtration, formulation, in-process testing, preparation of formulation components, and product development projects, in accordance with established Standard Operations Procedures (SOPs) and cGMP regulations. Supports the implementation of manufacturing procedures and production schedules. Effectively assists other personnel with technical issues and problems that may arise during the shift. Initiates revisions to current Master Batch Records, SOPs, and department desktop aids. Supports the maintenance of group production resources and assists with product development projects. Expected to operate production equipment, including the TFF system, Rotavap, Microfluidizer, Homogenizer, chiller, rotary lobe pump, high shear mixer, SIP, autoclave, depyrogenation oven, and CIP system. Maintains qualification to execute aseptic operations in GMP production facilities comprised of Grade A, B, C, and D manufacturing clean room areas. Supports routine maintenance and troubleshooting of production equipment. Accurately documents, completes, and reviews batch records, as needed. Coordinates and leads preparation of materials and components for sterilization in autoclave or dehydrogenation oven. Collaborates with other technical personnel on troubleshooting and engineering activities. Collects and disposes of lab waste according to established Safety, Health, and Environment (SHE) procedures. Maintains cGMP environment according to the production needs of the Drug Product group. May be required to interact and collaborate with clients and third-party vendors. Works closely with Production Planner to manage QAD work orders and ensure production materials are obtained according to the manufacturing schedule. Regular and reliable attendance on a full-time basis [or in accordance with posted schedule]. Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices. Embodies PCI Pharma Service’s cultural values and aligns daily actions with department goals and company culture. Requirements: High School Diploma required. Bachelor’s degree in a life sciences discipline or equivalent preferred. Minimum of zero to two (0-2) years of relevant experience in a manufacturing or laboratory environment. Detail oriented with strong written and verbal communication skills. Ability to work independently, within prescribed guidelines, or as a team member. Demonstrated ability to follow detailed directions in a manufacturing GMP environment. Familiarity with cGMP, manufacturing, machine operations, and data entry. Must be familiar with Microsoft Office applications. The base hourly range for this position is $21.69 to $24.40 plus annual performance bonus eligibility. Final offer amounts are determined by multiple factors including and not limited to specific and relevant experience, credentials, geography and subject matter expertise. Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future For Los Angeles applicants, we abide by the Fair Chance Initiative for Hiring. Learn more about the policy here: FCIHO Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture. #LI-KC1 Equal Opportunity Employer 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.
Under general direction, the Quality Assurance Inspector is responsible for monitoring and auditing the quality of manufactured goods using tools defined by the Quality Management System (QMS), Enterprise Resource Planning (ERP) system and process work instructions/methods. Responsibilities also include programming CMM machines to properly measure product to drawing specifications and standards. This position will participate with continual improvement initiatives and interact with all departments to provide support. Essential Functions: Plan and perform detailed inspections of materials, parts and assemblies using precision measuring equipment. Perform receiving, in-process, final and shipping inspections to ensure quality and conformance to specifications. Conduct First Article Inspections and generate First Article Inspection Reports (FAIR) in accordance with QMS requirements. Document all inspection results per company policies and requirements in the ERP system. Generate and process Non-Conforming Reports. Review and approve non-conformances (NC) and material review board (MRB) dispositions. Review documents and ensure requirements are met. Analyze reports and production data to identify trends and recommended updates to quality standards and procedures when necessary. Initiate correction/preventative action activities for nonconforming product including investigation, follow-up and root cause analysis. Participate in internal quality system audits for AS9100, ISO 13485, ISO 14001 as well as customer audits. Support FPC and defect trending activities as required by quality system. Set-up and run existing CMM programs. Program and calibrate the CMM. Perform and document maintenance as needed. Collaborate with Engineering and Production departments regarding measurement inspection matters. Work cross-functionally as a team to meet production/customer deadlines. Share knowledge and lead training in areas of expertise (i.e. measurement techniques). Support other departments or functions as needed, based on skill set and company priorities, to ensure operational efficiency and team success. Education, Experience, and Skills: To perform this job successfully, an individual must be able to satisfactorily perform each essential function. High School diploma. Minimum of 3 years of experience in quality assurance functions or similar. Experience working in contract manufacturing preferred. CMM set-up, operating and programming capabilities. Previous experience with and understanding of ISO9001, AS9100, ISO13485, ISO14001, AS9102, and FAR – DFAR documentation. Familiarity with quality testing tools and procedures required. Strong English communication skills. Must be able to create and write clear and detailed records and documents. Strong computer skills including Microsoft Office and must be able to perform assigned duties within the ERP system. Ability to work independently, stay focused, and perform in a fast-paced and deadline driven environment. Good analytical and problem solving skills, as well as a keen attention to detail. Strong interpersonal and teamwork skills are necessary to enable individual to work with all positions and personalities. Excellent customer service skills and understanding of building customer relationships. Physical Demands: The physical requirements for this position involve frequently remaining in a stationary position (sitting or standing) and frequently moving throughout all work centers. This position frequently lifts or carries 10lbs or less, occasionally lifts or carries object weighing 11-25lbs, and occasionally lifts 26-50lbs with assistance. This position occasionally reaches over head to move or measure product. This position requires the continuous use of hands/arms to operate a computer and to place and inspect material. This position continuously exchanges information with supervisors and coworkers regarding tasks and product. This position must be able to read drawings and work instructions and perceive color and fine detail. Compensation Range: QA Inspector: $23.00 - $27.00 per hour or D.O.E. What we offer: Medical, Dental, Vision, Voluntary Supplemental Benefits PTO plan with paid end of year shut down Supportive work/life balance culture 401(k) ITAR Requirements: This position requires use of information which is subject to the International Traffic in Arms Regulations (ITAR). All applicants must be U.S. persons within the meaning of ITAR. ITAR defines a U.S. person as a U.S. Citizen, U.S. Permanent Resident (i.e. 'Green Card Holder'), Political Asylee, or Refugee. MEI 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, disability or veteran status. Vv2eI19gAw
Company Description Who is Steico Industries? STEICO has made its name manufacturing precision tube and duct assemblies to the world's major airframe manufacturers. We manufacture tube and duct assemblies. We work with a wide variety of materials including aluminum, steel, titanium, and other alloys and produce parts of all complexities. STEICO holds accreditations with NADCAP and is certified to AS9100 and ISO14001. Our focus on responsiveness and continuous improvement regularly creates manufacturing innovation. STEICO is an integral part of our customers supply chains that include Boeing, Lockheed Martin, BAE, Northrop Grumman, Honeywell, Honda Aviation, and many others. About our parent company: Senior is an FTSE UK based international manufacturing Group with 26 operations in 12 countries. Senior designs, manufactures and markets high-technology components and systems for the principal original equipment producers in the worldwide aerospace, defense, and land vehicle and power & energy markets. We have a long history of well-respected brands and an excellent reputation in our key market sectors. Senior delivers value to its customers and shareholders via operational excellence that is underpinned by its people and processes. Senior’s experienced manpower support, effective use of raw material, and high technology enable it to deliver optimized components within a short development time and at most competitive prices. The Group is split into two divisions, Aerospace and Flexonics, servicing five key sectors. Our global values underpin what we do, and how we do it … Job Description AM Shift: Monday - Friday 6:00AM - 2:30PM* Pay: $30.00 - $33.00 an hour depending on experience Safety – Integrity – Customer Focus – Respect & Trust – Accountability – Excellence As a CNC Machinist you will: Set up and operate CNC Mill and mill Turn machine, including: vertical Mori Seiki DV5100, NLX 2500SY/700 Mill Turn, and other manual machine tools. What will my responsibilities include? Minor Manually program and edits CNC lathes/Mills using Fanuc control. Set up and operate 3, 5 axis CNC milling centers and CNC Lathes. Manually input (MDI) machine operations. Set up and operate multiple spindle CNC lathes and Mills. Set hard jaws and cut soft jaws to hold outside and inside diameters. Set hard jaws and cut soft jaws to hold outside and inside diameters. Use turning tools, boring bars, insert drills, reamers, inside groovers, outside groovers, part off tools, and threading tools. Know the difference between grades of inserts and radius of inserts. Use tool offsets and work offsets on CNC Mills and CNC lathes. Read and understand setup sheets and get all tools needed for setup of machine tool. Other reasonable duties as business and operational needs dictate Qualifications What key skills and experience do I need? Communication skills Written skills Education: High School diploma / General Education Completion. Minimum 4 years setup experience in setup of machines (CNC Lathes and CNC Mills) Knowledge of Mori NLX2500 Multi Axis Machines and Mori Mills with 5 axis or similar machines 1-2 years of set up experience Additional Information Why Join Steico Industries, Inc.? Joining Steico Industries, Inc. a company of Senior Plc. means not only a rewarding career with a tight-knit and collaborative team, but you will also enjoy a competitive compensation package that includes a market-led base salary and a comprehensive benefits package along with wellness benefits, employee recognition program, matching 401k plan, paid vacation, flexible hours, employee wellness activities, tuition reimbursement, and community involvement initiatives. Please understand that you will only be considered an applicant if you apply for a posted position directly through our Company website and meet the qualifications of the job. If you need a reasonable accommodation to apply, please contact the Steico Industries at 760-438-8015. Prior to an offer of employment, applicant employment references maybe requested. Trade Compliance Statement Access to our facilities is restricted under the International Traffic in Arms Regulations (ITAR) and/or the Export Administration Regulations (EAR) to U.S. Persons (U.S. Citizens, lawful permanent residents, U.S. Nationals, U.S. refugees, asylees, or temporary residents under amnesty provisions ), and to properly licensed foreign persons. Applicants receiving a conditional offer of employment will be required to provide information to determine whether they are subject to these regulations and, if so, to assess their country of chargeability for export control purposes. Additionally, potential employee names will be screened against the Consolidated Screening List (maintained by the United States government) to determine eligibility to receive controlled technical data. To ensure there is no unexpected delay to your start date with our Company and due to the potential need to obtain an export license, we would like to promptly assess whether such a license is needed to access our facility and/or systems. Such licenses can take several weeks/months to obtain from the U.S. Government. Our Trade Compliance department may reach out to you with a Licensing Assessment form, which we request you kindly complete and return as soon as possible. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. EOE M/F/D/V/VEVRAA Federal Contractor