GxP jobs in Pacheco, CA

Hybrid in San Francisco, California

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4d 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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9d 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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Third Party, Contract

$70 - $80

IT Project Manager with GxP

Remote

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3d ago

Title: IT Project Manager with GxP Location: Boston MA (1x Month) Duration: 6 Months Visa: No H1b Need an IT/Infrastructure PM with recent Pharma and GXP experience. Must have experience working with MSPs or Vendors Description: The Project Manager will be responsible for the end-to-end project lifecycle of multiple simultaneous IT projects in a GxP regulated environment. The PM will engage in new and in-flight projects to ensure project resources are aligned to deliver on schedule and within

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Full-time

70 - 75

Project Manager - Pinnacle 21, GXP | 100% Remote | Contract

Remote

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4d ago

Our direct client a large global R&D driven pharmaceuticals company is seeking to hire a Project Manager for their Pinnacle 21 upgrade project.This is 6 months plus contract. Job Title: Project Manager - Pinnacle 21 upgrade project Duration: 6 months (may extend) Location: 100% Remote (work per eastern time)Pinnacle 21 solution is critical for SQS.For this role client is looking for System upgrade experience as a Project Manager and from IT perspective.The tool provides the quality of submissio

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Contract

Depends on Experience

CAPA/QMS Quality Engineer (On-Site)(No Corp to Corp or H-1B)

Pacheco, California

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2d ago

Please note that this is a 12-18 Month Contract and is On-Site. No Corp to Corp or H-1B. JOB DESCRIPTION: Education: Science or Engineering: BS/MS/PhD or equivalent industry experience Required Experience: Minimum 5 years working in a Quality Engineer role in a regulated industry and experience interfacing with regulatory bodies Strong knowledge of quality management systems, including but not limited to ISO standards, GxP, and QSR Operations or Quality Experience in Medical Device Manufactur

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Contract

Depends on Experience

Facilities Maintenance Engineer

Pleasanton, California

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Today

Job Title: Facilities Maintenance Engineer Location: Pleasanton, CA (94588) Duration: 6 months with possibility of extension Project Background & Objective The laboratory and office facility operates highly complex, critical infrastructure supporting sensitive scientific research and corporate operations. To ensure maximum uptime, regulatory compliance, and asset longevity, we require a temporary, highly skilled Maintenance Engineer. The primary objective of this role is to audit, optimize,

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Contract

CSV Engineer

San Francisco, California

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Today

Roles & Responsibilities: Develop and implement validation strategies for computer systems and software applications. Create and maintain validation documentation, including Validation Plans, Protocols (IQ/OQ/PQ), and Validation Reports. Perform risk assessments to identify potential issues and ensure compliance with regulatory requirements. Collaborate with cross-functional teams, including IT, Quality Assurance, and Operations, to ensure successful validation of systems. Conduct validation tes

Full-time

Senior Staff Engineer - DevSecOps

Alameda, California

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Today

SUMMARY/JOB PURPOSE (Basic purpose of the job): Protect the organization's digital infrastructure, data, and systems from internal and external cybersecurity threats by implementing, managing, and continuously improving security practices, tools, and operations with a focus on cloud applications and infrastructure. ESSENTIAL DUTIES/RESPONSIBILITIES: Design and implement robust security architectures for cloud environments following best practices, industry standards, and regulatory requiremen

Full-time

USD 163,000.00 - 231,000.00 per year

Associate Principal Engineer - Analytics Platform

Alameda, California

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Today

SUMMARY/JOB PURPOSE (Basic purpose of the job): The Associate Principal Engineer - Cloud Platform will support the design and creation of cloud-based products and services to meet the technology needs of Exelixis. This position will help define and design our cloud platform, which includes cloud automation tools and standards, CI/CD pipelines, DevOps tooling and AWS account provisioning automation. This position will also work with application support teams to re-define the interface between ou

Full-time

USD 182,000.00 - 259,000.00 per year

Lead Solution Architect

Remote

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9d ago

Lead Solution Architect Remote (Eastern Time Zone) Location: Remote (must be available to work in the Eastern Time Zone)Travel: Up to 25% travel to client site in North Carolina as needed. About the RoleWe are seeking a highly skilled Enterprise Architect for a Greenfield manufacturing facility project, who will be the site team liaison between IT and business cross functional teams to ensure the quality delivery of 40+ digital capabilities for the new site from an architecture perspective.Key R

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Contract

Depends on Experience

Director, AI and Agentic Engineering

Alameda, California

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Today

SUMMARY/JOB PURPOSE The Director, Engineering AI and Agentic leads the strategy, architecture, delivery, and operations of enterprise AI platforms and AI-enabled business solutions. This role combines deep AI engineering leadership with strong product management capabilities to translate business needs into scalable, secure, measurable, and user-centered AI products. The Director, Engineering AI And Agentic is accountable for building reusable AI platform capabilities, delivering production-gra

Full-time

USD 215,000.00 - 306,000.00 per year

Agilent OpenLAB CDS Analyst

Remote

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2d ago

Job title: Agilent OpenLAB CDS Analyst Work Location: Rahway, NJ (Remote with Travel) Duration: Long Term Contract Job Description The Senior Technical Analyst will be responsible for supporting configuration, build, validation, & release activities for the successful release of a global enterprise Agilent OpenLAB CDS 2.x platform (OL:CDS), supporting and managing lab deployment resources in Agilent Instrument Controllers (AIC) builds, deployments, & troubleshooting efforts, and oversight of po

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Contract

Depends on Experience

Product Manager - Veeva Vault

Remote

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9d ago

Role: Veeva Vault Product Manager Location: Remote Job Type: FTE/ Full- Time Experience Range: 10- max 22 years Primary Skills: 1. Experience with system integrations (e.g., CTMS eTMF/EDC/Data Lakes & repositories) 2. Experience working with Siebel (CTMS) 3. Experience working with Veeva Managed Services or vendor escalations 4. Familiarity with Agile or DevOps methodologies 5. Knowledge of clinical metrics and reporting tools Required Bachelors degree in Life Sciences, Information Systems, o

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Full-time

Depends on Experience

Senior AI Data Scientist I

Alameda, California

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Today

SUMMARY/JOB PURPOSE The Senior AI Data Scientist I develops, trains and validates AI/ML models and analytics solutions that transform complex clinical datasets into analysis-ready deliverables supporting drug-development decisions. Leveraging statistical programming (R, Python, SQL) and machine-learning techniques, this role executes automated workflows, data quality assurance, and regulatory-compliant outputs within a GxP-governed clinical data pipeline. This position exists to advance the org

Full-time

USD 143,500.00 - 203,000.00 per year

Veeva Vault Product Manager

Remote

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5d ago

Veeva Vault Product Manager Clinical SME | Remote | FTE Location: Remote Employment: FTE Experience: 1022 Years We are hiring an experienced Veeva Vault Product Manager / Clinical Systems SME with strong expertise in Veeva Vault Clinical (CTMS & eTMF) and clinical trial operations. Key Requirements: 812+ years of experience delivering/leading regulated enterprise or clinical systems initiatives Deep hands-on experience with Veeva Vault Clinical CTMS & eTMF Strong understanding of clinical tria

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Full-time

Depends on Experience

AI Principal Engineer - Clinical Data Analytics

Alameda, California

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Today

SUMMARY/JOB PURPOSE The AI Principal Engineer - Clinical Data Analytics is a leader responsible for building and scaling data engineering and AI capabilities across the Development organization. This incumbent acts as a strategic business partner across Data Science and Statistics (DSS) functions, integrating data across domains to generate actionable, outcome-driven insights and AI capabilities, including Generative and Agentic AI. Owns data architecture, governed data products, and cloud-nati

Full-time

USD 172,000.00 - 245,000.00 per year

Associate Principal IT Product Lead - Technical Services

Alameda, California

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Today

SUMMARY/JOB PURPOSE: The Associate Principal IT Product Lead - Digital Applications, will lead a portfolio of digital products critical to Exelixis's success and ambition to launch innovative medicines for patients. This role is pivotal in driving the strategy, development, and operational excellence of our digital application ecosystem, ensuring alignment with business objectives and a strong focus on user experience and value delivery. Operating within a product-centric model, the Associate Pr

Full-time

USD 174,000.00 - 246,000.00 per year

Veeva Vault Product Manager

Remote or Hybrid in Foster City, California

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6d ago

HIRING: Veeva Vault Product Manager | Clinical Systems | Full - Time Role Location: Foster City, CA Onsite / Remote Experience: 10+22 Years We are looking for a Veeva Vault Product Manager / Clinical Systems Leader with strong hands-on experience across Veeva Vault Clinical, CTMS, and eTMF in a GxP-regulated pharmaceutical environment. Key Skills Required: Deep experience with Veeva Vault Clinical (CTMS & eTMF) Siebel CTMS experience Experience with CTMS eTMF / EDC / Data Lakes / reposito

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Full-time

Depends on Experience

Sr Director (Application and Data Strategy)

Hybrid in South San Francisco, California

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20d ago

Title: Sr Director (Application and Data Strategy) Location: Bay Area, CA Duration: 6-12 months Key Responsibilities Strategy & Portfolio Governance GxP Systems & Validation Implementation & Delivery Team Leadership & Operating Model Data, Security & Architecture Standards Additional Scope (Beneficial) Exposure to the following corporate application domains is a plus. These systems are managed in collaboration with HR, Finance, and Legal stakeholders: People & Culture (P&C): Workday HCM, ADP, L

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Contract, Third Party

$90 - $100

Senior Director, Light-Track Delivery & AI Automation

Remote

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Today

About Parexel Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere. We work with focus, agility, and shared purpose -- moving with urgency to address patient needs and accelerate

Full-time

GxP jobs in Pacheco, CA, USA