GxP jobs in California

Technical Project Manager - SaMD / GxP Validation

Remote

•

Today

Technical Project Manager - SaMD / GxP Validation. We need an independent, Quality-first project manager to drive an imaging algorithm Software as a Medical Device (SaMD) program in R&D IT toward a trial launch targeted for Q3. You will run the plan, clear blockers and own the validation documentation, all within a regulated Quality Management System (QMS). This is a technology role, not clinical operations, and we want someone who can start delivering in week one. Engagement 12-month contract

Contract

$60.00 - $80.00

GxP Project Manager (Pharma)

Hybrid in San Francisco, California

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9d ago

Job Title: GxP Project Manager Location: Bay Area, CA Duration: 6+ months with possible of extension Required Qualifications Bachelor's degree in Engineering, Computer Science, Life Sciences, Pharmacy, Biotechnology, or related field.8+ years of Project Management experience within the Pharmaceutical or Biotechnology industry.5+ years managing GxP-regulated projects.Strong understanding of GMP, GxP, GAMP 5, FDA regulations, and 21 CFR Part 11.Experience managing Computer System Validation (CSV)

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Third Party, Contract

$80 - $90

GXP Project Manager

Hybrid in San Francisco, California

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13d ago

About Nexinfo NexInfo is a consulting firm focused on improving business processes and automation in the Supply Chain and Product Lifecycle Management sectors. We offer services in business process design, software implementations, managed services, staff augmentation, and SaaS solutions. We aims to help businesses across industries achieve their goals through industry best practices, lean process design, and advanced software solutions. Our ERP-related services address challenges such as inven

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Contract, Third Party

$70 - $80

GxP Systems and Support Administrator

Remote

•

Today

Are You Ready? CAI is a professional services company established in 1996 that has grown year over year to nearly 800 people worldwide. For mission-critical and regulated industries that need to deliver critical solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard through our rigorous approach, field-tested processes, and elite expertise developed over 30 years. Our approach is simple because our Purpose inform

Full-time

USD 130,000.00 - 150,000.00 per year

Sr. Engineer, GxP Systems

Tustin, California

•

Today

Description Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes. Your Role: The Senior Engineer, GxP Systems leads the technical design, planning, implementation, administration, and support of enterprise systems, manufacturing equipment, and laboratory instrumentation

Full-time

USD 93,600.00 - 117,000.00 per year

SAP Validation

Remote

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23d ago

Job Title: SAP Validation Life Sciences & Pharmaceuticals Location: Remote Duration : Long term ONLY SAP VALIDATION PROFILES Required Qualifications Bachelor s degree in computer science, Information Technology, Engineering, Life Sciences, or related field. 8+ years of experience in SAP validation or Computer System Validation (CSV). GxP regulations 21 CFR Part 11 Annex 11 GAMP 5 Experience with validation tools and documentation management systems. Familiarity with change management and deviat

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Contract

Depends on Experience

Business Systems Analyst III

Remote

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6d ago

Business Systems Analyst LMS Transformation & SAP SuccessFactors Learning Migration Sumtotal LMS experience is required. 12 month remote contract. $40 an hour w2. No C2C or 1099 at this time. EST or CST candidates preferredPosition SummaryMilestone is seeking an experienced Business Systems Analyst (BSA ) to support the enterprise Learning Management System (LMS) transformation initiative, including the migration from SumTotal LMS to SAP SuccessFactors Learning. The BSA will serve as the li

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Contract

Depends on Experience

Business Systems Analyst III

Remote

•

6d ago

Business Systems Analyst LMS Transformation & SAP SuccessFactors Learning Migration12 month remote project - Candidates should sit in CST or EST time zone. $40 an hour w2. No Corp to Corp or 1099 support at this time. Position SummaryMilestone is seeking an experienced Business Systems Analyst (BSA ) to support the enterprise Learning Management System (LMS) transformation initiative, including the migration from SumTotal LMS to SAP SuccessFactors Learning. The BSA will serve as the liaison

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Contract

Depends on Experience

Business Systems Analyst III

Remote

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6d ago

Easy Apply

Contract

Depends on Experience

Business Systems Analyst III

Remote

•

6d ago

Easy Apply

Contract

Depends on Experience

Business Systems Analyst III

Remote

•

6d ago

Easy Apply

Contract

Depends on Experience

Program Manager with BA

Foster City, California

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2d ago

Role:Program Manager with BA Location:Foster City CA Fulltime Primary (Must have skills)*8+ years of experience in PM / Business Analysis with LifeScience domain 6+ Strong understanding of SDLC, support processes, and ticket managementworkflows. 4+ Experience with Azure DevOps (ADO)for activity tracking and project management. Strong stakeholder management, communication, and facilitation skills. Experience gathering and documenting business requirements and process flows. Ability to manage mul

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Full-time

Depends on Experience

Sr. IT/OT Infrastructure Engineer - Manufacturing Digitalization at Cincinnati, OH (Remote)

Remote

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9d ago

Position: Senior IT/OT Infrastructure Engineer - Manufacturing Digitalization Location: Cincinnati, OH (Remote) Duration: 3+ Months Job Description: We are seeking an experienced Senior IT/OT Infrastructure Engineer Manufacturing Digitalization to support manufacturing equipment digitalization, network connectivity, Data Integrity (DI) upgrades, MERA network onboarding, and VxRail infrastructure within a regulated manufacturing environment. The role will provide hands-on IT/OT infras

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Contract, Third Party

Depends on Experience

CSA/CSV Validation Consultant

Remote or Arlington, Virginia

•

Yesterday

Role - CSA/CSV Validation Consultant Remote Skills & Experience Required: empower or similar HPLC software Deep expertise in validating GxP-regulated IT systems within the Pharma/Life Sciences domain Familiarity with QMS processes including deviation management, CAPA, and change control. Strong command of CSA (Computer Software Assurance) principles Solid knowledge with 21 CFR Part 11, Annex 11, ISPE AI guidance, GxP data integrity principles (ALCOA+). Proven ability to write and manage valida

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Contract

Loftware Spectrum Technical Lead

Remote

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3d ago

Role : Loftware Spectrum Technical Lead / Solution Engineer Position Summary Responsible for the technical design, configuration, integration, support, and lifecycle management of Integer's Loftware Spectrum enterprise labeling platform. This role serves as the primary technical resource between Labeling COE, SAP, Oracle, manufacturing sites, Quality, and implementation partners to ensure a scalable, compliant, and supportable global labeling solution. The individual will lead architecture, busi

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Contract, Third Party

Depends on Experience

Validation Engineer

San Clemente, California

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9d ago

HonorVet Technologiesis a Service Disable Veteran-Owned IT staffing firm, ISO 9001, and ISO 27001 certified, working with federal agencies, state governments, and Fortune 500 enterprise clients across the US. What makes us different isn't a tagline; it's the way we work. We don't forward resumes and hope for the best. We take the time to understand where a professional like you are headed and only reach out when we genuinely believe there's a fit worth exploring. I came across your profile, and

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Contract

$38.94 - $48.65

AI-Driven Automation Engineer

Hybrid in Vacaville, California

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Yesterday

AI-Driven Automation Pharma ManufacturingLocation: Vacaville, CA Work Model: Hybrid 3 Days Onsite Duration: Long-Term Contract Job OverviewWe are seeking an experienced professional to drive AI-driven automation and process optimization within a regulated pharmaceutical manufacturing environment. The role will focus on requirements gathering, intelligent workflow automation, and improving end-to-end manufacturing operations through AI and digital technologies. Key ResponsibilitiesGather, analy

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Contract

Depends on Experience

Project Manager (Veeva Vault Clinical DR Validation Support) -Fulltime Role

Foster City, California

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28d ago

Senior Project Manager Vault Clinical DR ValidationFosters City CA Onsite - Full TImeExperience Range: 10-20 yearsIdeal candidate will have domain from Life Sciences, Pharmaceutical, Biotechnology, or Healthcare ( Not Healthcare Insurance)Primary skills(Must have skills)10+ years of Project Management experience,Experience in Disaster Recovery / DR project planning and coordinationExperience managing complex technical projects involving Project planning, scheduling, and milestone trackingRisk,

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Full-time

130,000 - 140,000

Validation Analyst

Hybrid in San Francisco, California

•

Yesterday

Role Overview Seeking an experienced Validation Analyst to support Roche's GIP program, focusing on validation of medical imaging applications, AI/ML workflows, and the Algorithm Workbench platform. The role will ensure system quality, regulatory compliance, data integrity, and end-to-end validation readiness. Key Responsibilities Develop and execute Computer System Validation (CSV) deliverables, including validation plans, risk assessments, IQ/OQ/PQ protocols, and validation summary reports.

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Full-time

60 - 70

AI Transformation & Architecture / Pharma

Vacaville, California

•

Yesterday

AI Automation & Process Optimization Consultant Pharma Manufacturing Location:- Vacaville, CA (Hybrid/ Onsite) Duration:- 12 Months+ We are currently seeking an AI Automation & Process Optimization Consultant for a 12+ month contract based in Vacaville, CA this is a hybrid/onsite role. This engagement supports a client's AI-Driven Automation for Pharma Manufacturing initiative, focused on requirements collection and process optimization. Role Overview: This engagement is centered on leveragi

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Third Party, Contract

Depends on Experience

GxP jobs in California, USA