PQ jobs in Pleasanton, CA

Senior Software Quality Assurance Engineer (SQE)

Pleasanton, California

•

Today

We are seeking a highly experienced and efficient Senior Software Quality Assurance (SQE) Engineer to join our Quality team. This critical role focuses on the validation and compliance of non-product, business-critical computerized systems in our regulated environment. The ideal candidate will have deep expertise in Computer System Validation (CSV) within design-controlled industries, ISO 9001 and ISO 13485 with a strong drive to automate all manual processes for increased effectiveness and reli

Full-time

USD 165,800.00 - 224,400.00 per year

Computer System Validation Analyst

Foster City, California

•

Today

Summary : Plan, lead, and execute the validation efforts for SCADA, Rockwell Factory Talk, PLC's and Ignition Create/write validation documentation (VP/URS/FS/DS/Trace Matrix/Risk Assessment/IQ/OQ/PQ, etc.) for process control systems. Author documents related to GxP Systems Draft Requirements and computer systems validation documents using GAMP 5 Execute test protocols for the software validation. Initiate and execute change management for existing qualified systems. Develop change management

Full-time

AWS Infrastructure Qualification & Validation Specialist

Redwood City, California

•

Today

Summary: We are seeking a skilled professional to lead and execute Infrastructure Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documentation for AWS-hosted environments. This role is critical in ensuring our cloud infrastructure meets regulatory compliance standards (e.g., GxP, HIPAA, ISO 27001) through robust validation and documentation practices. Roles & Responsibilities: Develop and maintain IQ/OQ/PQ documentation for AWS infrastructure components. C

Full-time

Senior Component Engineer

San Jose, California

•

Today

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 109,000.00 - 174,800.00 per year

Sr Mechanical Facilities Engineer II

Foster City, California

•

Today

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical ro

Full-time

USD 157,590.00 - 203,940.00 per year

Staff NPI Engineer - Shockwave Medical

Santa Clara, California

•

Today

Full-time

USD 125,000.00 - 201,250.00 per year

Computer System Validation Engineer 1

Remote

•

Today

Title: CSV Engineer 1 Location: Remote About: The CSV Engineer 1 will support Computer System Validation (CSV) activities for GxP-regulated systems. This role involves executing validation deliverables, ensuring compliance with FDA 21 CFR Part 11, EU Annex 11, and company quality standards. The candidate will work closely with IT, Quality, and Business teams to maintain a validated state of systems. Key Responsibilities Assist in the development and execution of validation documentation, inclu

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Contract

SAP PPQM PTS Consultant Remote

Remote or Atlanta, Georgia

•

Yesterday

Job Id: #CGEMJP00321513 Title: SAP PPQM PTS Consultant Location: Remote Duration: 12+ Months Position Summary: Job Role and Responsibilities: We are looking for a highly skilled Senior SAP PPQM Consultant with over 6 years of experience in SAP Production Planning (PP) and Quality Management (QM) modules, specifically within the pharmaceutical industry. The ideal candidate will have a deep understanding of GxP compliance, regulatory requirements, and validation documentation. This role involv

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Full-time, Part-time, Contract, Third Party

CSV and Validation Engineer

Remote or New Jersey

•

Today

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

Senior Supplier Engineer

Remote or Danvers, Massachusetts

•

Today

Full-time

USD 91,000.00 - 147,200.00 per year

Validation Engineer III

Remote or Durham, North Carolina

•

Today

Job Description Summary The Validation Engineer , is responsible for authoring, executing and reviewing/approval of SOP's, commissioning documentation, documents required for validation/qualification. Job Description Location: Durham, NC Please note this role is on-site 5 days a week and does not have the ability to work remotely. This role is based in Durham, NC. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. Responsi

Full-time

USD 89,600.00 - 166,400.00 per year

Senior CSV Engineer

Remote or Massachusetts

•

Today

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

CSV Lead Consultant

Hybrid in South San Francisco, California

•

Today

Position: CSV Lead Consultant Location: South San Francisco, CA (Hybrid, 3 days/week onsite) Position type: 12+ Months (with possible extension) Job description: This is a hybrid role for a CSV Lead, located in South San Francisco, CA with some flexibility for remote work. The individual will oversee computerized system validation efforts, ensuring compliance with regulatory and quality standards. Key tasks include planning, developing, and executing validation strategies for systems such as

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Third Party, Contract

Depends on Experience

Systems Administrator / Technical Lead – Process Control Systems

Foster City, California

•

29d ago

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, administeri

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Contract

65 - 70

Veeva Migration Consultant

Remote

•

27d ago

We have a below position for Veeva Migration expert for remote work, please find the JD below and let me know your interest. Title: Veeva Migration Consultant Exp: 7+ to 10 years of experience in Veeva migration and implementation activities Duration: 6-12 Months Responsibilities: Migration Work stream Lead-Veeva RIMS Implementation Key Responsibilities Migration Strategy & PlanningDefine migration scope, timelines, resources, and success metrics.Develop detailed migration plans and risk mitiga

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Contract, Third Party

Depends on Experience

LabVantage LIMS Configurator

Remote

•

Today

RAYVEN IT Solutions is a leading IT Consulting firm offers a comprehensive range of services that are domain specific with a strong focus on technology, business process & practices. Founded by top-notch profs with the vision of bridging the gap between people, process & technology. RAYVEN has the capability & resources to help clients realize their technology driven business transformation initiatives. We are specialized & provide solution-based services to our clients in the areas of SAP/ERP.

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Contract, Third Party

Depends on Experience

CSV ENGINEER | COLUMBUS, OH (REMOTE)

Remote or Columbus, Ohio

•

Today

ONLY 1099 JOB TITLE: CSV ENGINEER JOB DURATION: 1 YEAR JOB LOCATION: COLUMBUS, OH (REMOTE) EXPERIENCE: 8+ YEARS VISA: , - 1099 Job Domain Healthcare Industry Job Description Role: The CSV Engineer 1 will support Computer System Validation (CSV) activities for GxP-regulated systems. This role involves executing validation deliverables, ensuring compliance with FDA 21 CFR Part 11, EU Annex 11, and company quality standards. The candidate will work closely with IT, Quality, and Business te

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Contract

USD 55-60

Mechanical Design Engineer

Sunnyvale, California

•

Today

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

Computer System Validation (CSV) Engineer

Remote or Massachusetts

•

Today

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

Full-time

CSV Engineer

Santa Clara, California

•

Today

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

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PQ jobs in Pleasanton, CA, USA