GXP Jobs in California

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Technical Writer (GxP with Healthcare/Pharma/Lifescience domain)

Ab Ovo Inc

•

Santa Monica, California, USA

Contract

One of our direct Pharmaceutical client is looking to hire Technical Writer (GxP with Healthcare/Pharma/LifeScience domain) - at Santa Monica, CA (Hybrid). Seeking a skilled Technical Writer to create and maintain documentation related to Protected Health Information (PHI), Good Practice (GXP) guidelines, and healthcare quality standards. The ideal candidate will have a strong background in healthcare regulations, excellent writing skills, and the ability to produce clear and accurate documenta
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Posted 7 days ago | Updated 2 days ago

Senior Pharma GxP Project Manager with a strong background in SAP S/4 HANA validation

Pioneer Corporate Services Inc

•

Foster City, California, USA

Contract, Third Party

Job Title: Senior Pharma GxP Project ManagerLocation: Hybrid Foster City, CA (Locals or nearby states preferred)Duration: 12 Months Job Description:We are seeking a Senior GxP Project Manager with a strong background in SAP S/4 HANA validation and Life Sciences industries. The role demands excellent stakeholder and change management skills, hands-on validation expertise, and solid project leadership. Must-Have Skills: 15 20 years of overall experience 8+ years in Computer System Validation (CSV)
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Posted 2 days ago | Updated 2 days ago

GxP Business Analyst/Project Manager

Eliassen Group

•

Anywhere, US

Contract

Description: **Remote** Our Biotechnology client is looking for a GxP Business Analyst/Project Manager to come on for a long-term contract. This person is needed to help "keep the lights on" with respect to legacy systems that are being used for submissions to meet regulatory requirements across the globe. Regulatory requirements are constantly evolving, and our client has to keep product documentation up to date in order to be in compliance and continue to do business in different countries
Posted 60+ days ago | Updated 5 hours ago

Technical Writer

SPECTRAFORCE TECHNOLOGIES Inc.

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Santa Monica, California, USA

Contract

Technical Writer Santa Monica, CA 90404 (Onsite) 6 Months Job Summary: We are seeking a skilled Technical Writer to create and maintain documentation related to Protected Health Information (PHI), Good Practice (GXP) guidelines, and healthcare quality standards. The ideal candidate will have a strong background in healthcare regulations, excellent writing skills, and the ability to produce clear and accurate documentation. Key Responsibilities: Develop, write, and maintain documentation for PHI,
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Posted 8 days ago

IT Project Manager Lead V - LIMS - Laboratory Information Management System/ LabVantage

Javen Technologies, Inc

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Remote

Contract

Job Title: IT Project Lead V LIMS Project Manager< class="MsoNormal">Location: Remote< class="MsoNormal">Duties: < class="MsoNormal">This role will assist with the implementation of a new Laboratory Information Management System (LIMS) and Electronic Lab Notebook (ELN) to be used across the organization starting in 2026.< class="MsoNormal">Domain Knowledge:<>Experience with LIMS (Laboratory Information Management Systems) preferably LabVantage<>Understanding of clinical, research, or diagnostic
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Posted moments ago | Updated moments ago

Business Analyst

NTT DATA Americas, Inc

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Remote or Pittsburgh, Pennsylvania, USA

Contract

Company Overview: Req ID: 328701 NTT DATA strives to hire exceptional, innovative and passionate individuals who want to grow with us. If you want to be part of an inclusive, adaptable, and forward-thinking organization, apply now. NTT DATA's Client is currently seeking a Cybersecurity Business Analyst to join their team in Pittsburgh, Pennsylvania (US-PA), United States (US). (REMOTE)Job Description: Experience Level: 7-9 years of relevant experience Role Overview: The Business Analyst (BA) wil
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Posted 1 day ago | Updated moments ago

IT Project Lead V - LIMS Project Manager

Javen Technologies, Inc

•

Remote

Third Party, Contract

Job Title: IT Project Lead V Location: Remote. Duration: 15+ Months (Extendable) Duties: This role will assist with the implementation of a new Laboratory Information Management System (LIMS) and Electronic Lab Notebook (ELN) to be used across the organization starting in 2026. Domain Knowledge: Experience with LIMS (Laboratory Information Management Systems) preferably LabVantageUnderstanding of clinical, research, or diagnostic lab workflowsKnowledge of regulatory requirements (GxP, FDA 21 CFR
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Posted 1 day ago

Senior Business Management Consultant (32660)

Myticas LLC

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Remote or Chicago, Illinois, USA

Contract

Senior Business Management Consultant Location: Waukegan, IL (3 days onsite) Company: Myticas's direct client based in North Chicago, IL MUST Have: 8-10 years of Senior IT project experience: System Lifecycle (SLC) Expertise. Portfolio / Program management experience. Project financial management, and vendor management expertise. GXP system experience required - GXP system implementation including custom development and validated systems. Description: Senior Business Management Consultant to
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Posted 14 hours ago | Updated 2 hours ago

Veeva Presales Consultant

NexInfo Solutions, Inc.

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Remote

Contract

Title: Veeva Presales ConsultantLocation: Remote Client Engagement & SolutioningEngage with potential clients to understand their business challenges, current system landscape, and digital transformation needs.Lead discovery sessions to gather functional and technical requirements relevant to Veeva Vault solutions (e.g., Veeva CRM, Vault Quality Docs, RIM, eTMF, PromoMats, etc.).Articulate the value proposition of Veeva products and services in the context of customer-specific use cases.Content
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Posted 24 days ago | Updated 14 hours ago

LIMS - Laboratory Information Management Systems

Javen Technologies, Inc

•

Remote

Contract, Third Party

Experience with LIMS (Laboratory Information Management Systems) preferably LabVantage Understanding of clinical, research, or diagnostic lab workflows Knowledge of regulatory requirements (GxP, FDA 21 CFR Part 11) Familiarity with lab instruments, integrations, and data flows Working with ELNs (Electronic Lab Notebooks) and lab automation Basic understanding of data security, validation, and integrity in lab system Skills: Business Analysis Skills: Requirements gathering and documentation Proce
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Posted 1 day ago | Updated moments ago

Engineer III, Validation

Thermo Fisher Scientific

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Remote or Waltham, 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: Engineer , Validation HOURS: Monday to Friday, 8:00 am to 5:00 pm DUTIES: Perform technical diagnosis of operational problems, repairs, and calibrations on a wide range of laboratory equipment to ensure that the equipment is operating to the customer's complete satisfaction and manufacture specifications; Perform techn
Posted 25 days ago | Updated 5 hours ago

LIMS and QC Applications Consultant

Expedite Technology Solutions

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Remote or Bridgewater, New Jersey, USA

Full-time, Contract

Solution Architecture and Design: Lead the design and development of LabVantage LIMS solutions tailored to business and laboratory needs. Develop system workflows, configurations, and integrations with other enterprise systems (e.g., S4 Hana ERP, MES, ELN, SDMS). Define data models, interface designs, and system configurations. Implementation and Deployment: Oversee installation, configuration, and validation of LabVantage LIMS applications. Develop and execute project plans, ensuring timely an
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Posted 60+ days ago | Updated moments ago

Global IT Compliance Sr Specialist

Thermo Fisher Scientific

•

Pennsylvania, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing so
Posted 12 days ago | Updated 5 hours ago

System Validation Engineer

Katalyst Healthcares and Lifesciences

•

Santa Clara, California, USA

Full-time

Responsibilities: Develop, implement, and maintain software quality assurance processes for non-product software used in medical device development. Ensure adherence to regulatory standards (FDA, ISO 13485, IEC 62304) and industry best practices for non-product software. Support audits and inspections by regulatory bodies, ensuring that non-product software systems comply with quality and documentation standards. Ensure computerized systems are appropriately validated Assessment of applicabi
Posted 7 days ago | Updated 5 hours ago

Medical Device & Regulations Engineer

Katalyst Healthcares and Lifesciences

•

Santa Clara, California, USA

Full-time

Responsibilities: Develop, implement, and maintain software quality assurance processes for non-product software used in medical device development. Ensure adherence to regulatory standards (FDA, ISO 13485, IEC 62304) and industry best practices for non-product software. Support audits and inspections by regulatory bodies, ensuring that non-product software systems comply with quality and documentation standards. Ensure computerized systems are appropriately validated Assessment of applicabil
Posted 12 days ago | Updated 5 hours ago

Computer System Validation (CSV) Engineer

Katalyst Healthcares and Lifesciences

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Remote or Massachusetts, USA

Full-time

Responsibilities: Lead and execute CSV activities across GxP-regulated systems (LIMS, MES, ERP, etc. Author 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
Posted 15 days ago | Updated 5 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 5 hours ago

Tosca Test Architect

HPTech Inc.

•

San Francisco, California, USA

Contract, Third Party

Job Title: Tosca Test Architect SAP S/4HANA Test Automation Location: Bay Area (Mandatory to be in office every week) Experience: 10+ years in QA with 3+ years as Test Architect Industry: Life Sciences Job Summary: We are seeking a seasoned Tosca Test Architect to lead the automation strategy and test architecture for SAP S/4HANA implementations, specifically focusing on Plan-to-Make and Order-to-Cash business processes. The ideal candidate will bring deep expertise in Tosca, SAP testing framew
Easy Apply
Posted 20 hours ago | Updated 20 hours ago

Lead Engineer - MES Opcenter

Katalyst Healthcares and Lifesciences

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Remote or New York, USA

Full-time

Job Description: The Lead Engineer will lead a team of technical resources to design, develop, configure, and test MES (Manufacturing Execution Systems) solutions. They will be directly responsible for leading resources contracted vi third-party and through other Pharmaceutical organizations to develop & deploy MES application software to Medical Device manufacturing sites globally. Responsibilities: Act as subject matter expert on system design and architecture. Solutioning and designing new
Posted 24 days ago | Updated 5 hours ago

Senior Manager, Third-Party Cyber Risk Assessment

Johnson & Johnson

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Remote or Raritan, New Jersey, 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 5 days ago | Updated 5 hours ago