OQ Jobs in California

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Component Engineer - Validation (IQ/OQ/PQ)

Katalyst Healthcares and Lifesciences

•

Irvine, California, USA

Full-time

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.
Posted 16 days ago | Updated 9 hours ago

Sr. Engineer, Packaging

Cardinal Health

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Remote or El Paso, Texas, USA

Full-time

What Packaging Engineering contributes to Cardinal Health Packaging Engineering is responsible for designing, developing and testing a wide variety of equipment and packaging used for protection, display and handling of products. Determines packaging specifications, cost limitations, legal requirements, and related documentation. Directs external resources / contractors as required. The ideal candidate would be located in the El Paso, Texas area and this position is a hybrid role. Responsibilit
Posted 9 days ago | Updated 8 hours ago

Computer System Validation (CSV) Engineer

Katalyst Healthcares and Lifesciences

•

Remote or Massachusetts, USA

Full-time

Responsibilities: Lead and execute CSV activities across GxP-regulated systems (LIMS, MES, ERP, etc. uthor and maintain validation deliverables: URS, FS, DS, IQ, OQ, PQ, and traceability matrices. Ensure systems comply with 21 CFR Part 11, EU Annex 11, and GAMP 5. Support system implementations, upgrades, and periodic reviews. Collaborate with QA, IT, and business users to drive validation strategy. Participate in audits and inspections to demonstrate compliance. Requirements: Bachelor's degree
Posted 20 days ago | Updated 9 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

•

Thousand Oaks, California, USA

Full-time

Responsibilities: Plan and track implementation of commissioning & qualification actions/documentation versus project(s) timelines. Author/evaluate qualification/validation protocols including DQ, IQ, OQ, FT, PQ protocols and final reports for new or modified GMP utilities, facilities, and process equipment. Execute DQ, IQ, OQ, FT, PQ protocols, which involve protocol discrepancies, investigation, and corrective action activities for new or modified GMP utilities, facilities, and process equi
Posted 60+ days ago | Updated 8 hours ago

Computer System Validation Engineer

Katalyst Healthcares and Lifesciences

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Remote or New Jersey, USA

Full-time

Roles & Responsibilities: Full lifecycle validation for all applicable computerized systems, ensuring they are designed, validated, operated and retired in compliance with GxP regulation and computer system validation (CSV) guidance. Compiling and maintaining accurate CSV documentation, ensuring full traceability throughout system lifecycles. Compliance Analysis, Validation Planning, Risk Assessments Test planning and strategy creation and execution of test protocols, scripts and reports. V
Posted 60+ days ago | Updated 9 hours ago

Senior Commissioning, Qualification & Validation (CQV) Engineer

Johnson & Johnson

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Remote or Athens, Georgia, USA

Full-time

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
Posted 17 days ago | Updated 9 hours ago

Validation Engineer

Katalyst Healthcares and Lifesciences

•

Los Angeles, California, USA

Full-time

Responsibilities: Conceives, plans and executes manufacturing process validations plans and studies. dhere to the Change Control and Design Control requirements. To create robust validation documents such as Master Validation Plans / Report, IQ, OQ, & PQ's. Being the lead on the writing and execution of IQ/OQ/PQ protocols. RCH/PCH - Routing in MAP Agile & follow up till release. Updating Control Plan (CP), Assembly Procedure (AP) & Traveler document (TD). Preparing protocol & executing Test Meth
Posted 60+ days ago | Updated 8 hours ago

Senior Staff Engineer, R&D Packaging

Stryker

•

Fremont, California, USA

Full-time

Work Flexibility: Hybrid Stryker Neurovascular focuses on saving lives: Treating and preventing strokes is our mission. From the moment a product is manufactured to its use in the angio suite, the packaging and labeling make a difference in so many ways. As a Senior Staff Engineer, R&D Packaging, you will be a key member on new product development project teams, driving the design and development of packaging components, artwork, design verification, shelf life testing, label design, and suppor
Posted 22 days ago | Updated 9 hours ago

Compliance Lead

Adva IT Services, Inc..

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Remote

Contract

Key Responsibilities Lead the design and execution of the company s compliance framework, covering GxP areas (GMP, Google Cloud Platform, GLP) and validated system lifecycle activities. Ensure compliance with SDLC processes for GxP-relevant computerized systems, including documentation, validation, change control, and audit readiness. Develop and maintain SOPs and training programs related to software/system validation and data integrity (e.g., per 21 CFR Part 11 and Annex 11). Provide complianc
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Posted 6 days ago | Updated 1 day ago

Sr. Validation Engineer (CSV)

Katalyst Healthcares and Lifesciences

•

California, USA

Full-time

Responsibilities: Create and execute Computer System Validation (CSV) deliverables (Validation Plans, Protocols, Reports, Trace Matrices, SOPs). Collaborate with Business Users, System Owners, IT teams, and Analysts to define validation requirements. Provide leadership and training in validation activities. Generate IQ/OQ/PQ protocols using Good Documentation Practices (GDP). Ensure compliance with quality system elements for computer systems/software testing. Perform gap assessments and remedia
Posted 60+ days ago | Updated 8 hours ago

Sr. Manufacturing Engineer

Sanmina-SCI

•

San Jose, California, USA

Full-time

Sanmina Corporation (NASDAQ: SANM) is a leading integrated manufacturing solutions provider serving the fastest-growing segments of the global Electronics Manufacturing Services (EMS) market. Recognized as a technology leader, Sanmina Corporation provides end-to-end manufacturing solutions, delivering superior quality and support to Original Equipment Manufacturers (OEMs) primarily in the communications networks, defense and aerospace, industrial and semiconductor systems, medical, multimedia, c
Posted 19 days ago | Updated 1 day ago

CSV/ CSA Engineer

Katalyst Healthcares and Lifesciences

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San Francisco, California, USA

Full-time

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. Responsibilities: 10 Plus Years of experience in Computer System Assurance (CSA) or Computer System Validation (CSV) in regulated industries such as pharmaceuticals, medical devices, or biotechnology. Stron
Posted 60+ days ago | Updated 9 hours ago

Validation Lead, SAP S4 HANA

Katalyst Healthcares and Lifesciences

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Remote or New Jersey, USA

Full-time

Responsibilities: Lead the validation team in a strategic, risk-based approach that optimizes legacy Computer System documentation, CSA strategies and strong SAP ECC->S/4 HANAconversion knowledge to successfully deliver a validated system meeting all project requirements. Review, approval, and processing of Computer System Lifecycle deliverables including: User Requirements, Specifications, Test Plans, IQ, OQ, PQ Test Scripts, User Guides. Fostering of effective relationships with implementati
Posted 60+ days ago | Updated 8 hours ago

Manager, IT/Senior Systems Analyst

Thermo Fisher Scientific

•

Massachusetts, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description COMPANY: Thermo Fisher Scientific Inc. LOCATION: 168 Third Avenue, Waltham, MA 02451 TITLE: Manager, IT/Senior Systems Analyst HOURS: Monday to Friday, 8:00 am to 5:00 pm DUTIES: Support Thermo Fisher's integration of Tracelink (Track and Trace Solution) and Thermo Fisher's downstream partners to ensure Thermo Fisher is compliant with Serialization and Track and Trace requirements and detailing the technical
Posted 39 days ago | Updated 8 hours ago

Mechanical Design Engineer

Katalyst Healthcares and Lifesciences

•

Sunnyvale, California, USA

Full-time

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 imp
Posted 4 days ago | Updated 9 hours ago

Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and Lifesciences

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Remote or New Jersey, USA

Full-time

Responsibilities: Lead validation planning, risk assessment, and execution for R Studio, GitLab, and Medidata Rave EDC. Develop and execute validation documentation including: Validation Plans (VP.). User Requirements Specifications (URS.). Risk Assessments (RA.). Functional and Design Specifications. Traceability Matrix (RTM.). Test Protocols (IQ/OQ/PQ or CSA-based scripts.). Validation Summary Reports (VSR.). Collaborate with cross-functional stakeholders including Clinical Data Mana
Posted 60+ days ago | Updated 9 hours ago

Sr. Analyst, IT Validation Services

Russell, Tobin & Associates

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Remote or Stamford, Connecticut, USA

Contract

Job Title: Sr. Analyst, IT Validation Services Location: Remote Duration: 12 Months Pay Range: $30/hr-$35/hr on W2 (DOE) Primary Responsibilities Creation, review, approval, and DMS processing of Computer System Lifecycle deliverables for Projects and Change Controls: Validation Plans/Summary Reports Risk Assessments User Requirements Specifications Test Plans Test Scripts: IQ, OQ or PQ Assess and implement the most effective validation strategy for each activity. Oversee test execution for c
Easy Apply
Posted 60+ days ago | Updated moments ago

Supplier Engineer II

Johnson & Johnson

•

Remote or Danvers, Massachusetts, USA

Full-time

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
Posted 60+ days ago | Updated 9 hours ago

Systems Administrator / Technical Lead - Process Control Systems

Katalyst Healthcares and Lifesciences

•

Foster City, California, USA

Full-time

Job Summary: We are looking for an experienced professional who will be responsible for administration of Rockwell FactoryTalk-based process control systems and Inductive Automation's Ignition-based process control and environmental monitoring systems. The candidate should have hands-on experience deploying, configuring, and troubleshooting these systems in a Good Manufacturing Practice (GMP) environment, with a good understanding of FDA regulations. This role focuses on deploying system updates
Posted 60+ days ago | Updated 8 hours ago

Quality Engineer II

Orchid Orthopedic Solutions

•

Santa Ana, California, USA

Full-time

ABOUT US Orchid Orthopedic Solutions is world leading Medical Device Contract Design and Manufacturing company that offers a comprehensive portfolio of services for implants and instruments with significant experience in the joint reconstruction, spine, trauma, dental and sports medicine markets. T his site focuses primarily on Swiss style turning for the trauma, spine and dental markets. We are also FDA registered and ISO 13485 certified. A career with Orchid provides training and growth oppor
Posted 60+ days ago | Updated 1 day ago