OQ jobs in California

Component Engineer - Validation (IQ/OQ/PQ)

Irvine, California

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Yesterday

Job Description: Experienced Component Engineer with strong expertise in equipment and process validation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Proven ability to manage component selection, supplier coordination, and quality documentation to ensure compliance with FDA, ISO 13485, and GMP standards. Roles & Responsibilities: Component validation activities including creation and execution of IQ/OQ/PQ protocols and reports.

Full-time

Senior CSV Engineer

Remote or Massachusetts

•

Yesterday

Job Description: We are looking for a Senior Computer System Validation (CSV) Engineer to perform validation of computerized systems associated with Client's facilities, utilities, and equipment for the qc lab validation project. This role will focus on EMS, Client, and laboratory informatics/software platforms (e.g., HPLC/qPCR control software, Sicknotes, Blue Mountain), ensuring compliance with 21 CFR Part 11, Annex 11, and data integrity requirements. The CSV Engineer will obtain documentatio

Full-time

GMP Tester / Validation Engineer

Vacaville, California

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Yesterday

Job Description: We are seeking a skilled GMP Tester / Validation Engineer with strong experience in testing and validating applications in regulated environments (GMP, GxP, Pharma, Life Sciences). The ideal candidate will have hands-on expertise in validation testing, documentation, and compliance for critical applications such as MES, LIMS, ArchestrA, and manufacturing systems. This role requires a detail-oriented professional who can design and execute validation tests, review traceability ma

Full-time

Field Service Engineer II

Remote or Raleigh, North Carolina

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Yesterday

Work Schedule Standard (Mon-Fri) Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc allowed, Laboratory Setting, Loud Noises (Equipment/Machinery), Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biolog

Full-time

CSV Engineer

San Francisco, California

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Yesterday

Job Description: The CSA Engineer will be responsible for ensuring that all computer systems, software applications, and related processes comply with industry standards and regulatory requirements, especially in regulated environments such as pharmaceutical, biotech, and healthcare sectors. Roles & Responsibilities: 10Plus Years of experience in Computer System Assurance (CSA) or Computer System Validation (CSV) in regulated industries such as pharmaceuticals, medical devices, or biotechnol

Full-time

CSV and Validation Engineer

Remote or New Jersey

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Yesterday

Job Description: We are seeking a hands-on CSV and Validation Engineer to validate software used with laboratory instruments and lab informatics platforms. The role owns risk-based validation planning and execution aligned to EMA Annex 11 and 21 CFR Part 11, authors audit-ready documentation, and partners with QA/IT/Lab to transition systems to standardized SOPs. Responsibilities: Plan and execute computer system validation using a risk-based CSA approach aligned to GAMP 5. Validate instrument

Full-time

Inari Medical Staff R&D Process Development Engineer

Irvine, California

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Yesterday

Work Flexibility: Onsite We are seeking a talented Process Development Engineer to support the development and commercialization of our next generation thrombectomy system. This engineer will play a critical role in developing and validating manufacturing processes that enable reliable production of highly complex interventional devices, with strong collaboration with R&D engineering. This role is fully onsite role in Irvine, CA with the expectation to be in office 5 days a week. Check out ou

Full-time

USD 100,700.00 - 165,100.00 per year

SAP Validation Lead

Foster, California

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Yesterday

Job Description: We are seeking an experienced SAP Validation Lead to drive Computer System Validation (CSV) efforts for SAP systems in a regulated environment. The ideal candidate will ensure SAP implementations and enhancements comply with GxP, FDA 21 CFR Part 11, Annex 11, and industry validation standards. This role requires deep expertise in SAP validation, SDLC methodologies, risk-based validation approaches, and change management processes. You will collaborate closely with Business, IT,

Full-time

Component Engineer 3

Sunnyvale, California

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3d ago

Primary Function of the Position: Responsible for ensuring suppliers meet ISI requirements for quality, service, delivery, and cost. Drive suppliers to continuously improve business and manufacturing processes. Evaluate and select suppliers. Guide Engineering in choosing suppliers for new products and provide DFM input to new designs. Supports both NPI and on-going production, monitors and works with suppliers to improve supplier performance. Executes detailed projects with suppliers to impleme

Easy Apply

Contract

$74 - $74

Test Engineer 3

Sunnyvale, California

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3d ago

Roles and responsibilities. Essential duties. Generate and take ownership of test protocol design, strategy, test execution, trace matrix, test report, artifacts, and related activities. Perform all upstream and downstream requirements tracing using tools such as Polarion or equivalent Develop and execute test protocols for product labels Clearly document test results and observations in test reports Review and recommend improvements to test methods, leverage/incorporate industry best prac

Easy Apply

Contract

$75 - $75

Senior Supplier Engineer

Remote or Danvers, Massachusetts

•

Yesterday

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m

Full-time

USD 91,000.00 - 147,200.00 per year

Supplier Engineer, Electrical Systems

Remote or Danvers, Massachusetts

•

Yesterday

Full-time

USD 77,000.00 - 124,200.00 per year

Senior Specialist DDIT OPS, Automation Engineer

Carlsbad, California

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Yesterday

Job Description Summary The Senior Specialist DDIT OPS, Automation Engineer will oversee and lead the IT/OT team to ensure reliable 24/7 operations of the manufacturing plant, providing technical support, system maintenance, and issue resolution to minimize downtime and optimize plant performance. Job Description Major accountabilities: IT/OT Team Leadership & Incident Management: Lead the IT/OT team in managing and resolving incidents promptly, ensuring seamless plant operations and minimizin

Full-time

USD 108,500.00 - 201,500.00 per year

Principal Engineer, Tooling

Remote or Connecticut

•

Yesterday

Job Description Position Summary The primary function of this job is to lead the execution of plastic components strategies and initiatives for ICU Medical Device products. These strategies will be defined by the Operations team with inputs from the stakeholders. Stakeholders include: PMOs, R&D, Operations, Procurement, and Supplier Quality. This position will lead the execution of tooling, equipment, and manufacturing processes relative to plastics. Represents the Advanced Manufacturing Engin

Full-time

Principal R&D Engineer (Extrusion) - Shockwave Medical

Santa Clara, California

•

Yesterday

Full-time

USD 141,000.00 - 227,700.00 per year

Engineer Sr I - Manufacturing - (Mechanical & Electrical) 1

Goleta, California

•

Today

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education. We are a privately held company that strives to accomplish our corporate mission of Helping Surgeons Treat Their Patients Better . We are committed to delivering uncompromising quality to the health care professionals who use our products, and ultimately, the millions of patients whose lives we impact. Arthrex Benefits Medical, Dental and Vision Insurance Company-Provided Life Insura

Full-time, Contract

From USD 92000.0 to 117875.0 per year

Mechanical Design Engineer

Sunnyvale, California

•

Yesterday

Job Description: Responsible for ensuring suppliers meet ISI requirements for quality, service, delivery, and cost. Drive suppliers to continuously improve business and manufacturing processes. Evaluate and select suppliers. Guide Engineering in choosing suppliers for new products and provide DFM input to new designs. Supports both NPI and on-going production, monitors and works with suppliers to improve supplier performance. Executes detailed projects with suppliers to implement changes and im

Full-time

Validation Engineer

Irvine, California

•

Yesterday

Job Description: The Senior Validation Engineer will serve as a subject matter expert in validation, leading critical projects in support of GMP-compliant manufacturing and product development. This role involves strategic planning, execution, and continuous improvement of validation processes across multiple sites, while supporting audits, risk assessments, and global quality initiatives. Responsibilities: Interpret and implement validation requirements based on FDA regulations, corporate stan

Full-time

CSV Engineer

Santa Clara, California

•

Yesterday

Job Description: The CSV Engineer will play a critical role in ensuring that all computerized systems used in the manufacturing and quality systems of medical devices are validated according to applicable regulations such as FDA 21 CFR Part 11, EU Annex 11, and ISO 13485. This role ensures the systems are compliant, reliable, and fit for intended use, supporting quality and regulatory requirements across the organization. Responsibilities: Develop and execute Computer System Validation (CSV) de

Full-time

MES Analyst

San Jose, California

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17d ago

MES Analyst Bay Area, CA - Locals only6+ Months Top Skills: Siemens Opcenter MES and CAMSTAR Manufacturing Consulting Medical DevicesJob Description: A dynamic professional with proven expertise in Siemens Opcenter Medical Devices in Manufacturing Execution domain. Design and architect multi-site MES Opcenter implementation based on discussion with business teams and their processesShould have Experience on LOFTWARE PRISYM 360 Understand the paper Batch record and business process flow in collab

Easy Apply

Contract, Third Party

$60 - $70

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OQ jobs in California, USA