21 CFR Part 11 jobs

Project Manager/ Business Analyst (Clinical Operations)

Hybrid in Foster City, California

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13d ago

Job Title: Project Manager/ Business Analyst (Clinical Operations) Location: Foster City, CA (Hybrid)Employment Type: Full-Time (FTE) Job SummarySeeking a Senior Project Manager / Business Analyst with strong Clinical Operations expertise and hands-on experience in Risk-Based Monitoring (RBM/RBQM). Responsible for requirements gathering, project delivery, stakeholder management, and implementation of clinical systems and monitoring processes. Key ResponsibilitiesLead requirements gathering for R

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Full-time

$160,000 - $160,000

Lab Project Manager(W2 Role)

Boston, Massachusetts

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4d ago

No C2C or agency resumes, please. Please do not enquire or submit candidates if you are an agency or if the candidate is available on a C2C basis. Role: Lab Systems Project Manager Benchtop Systems Location: Boston, MA (Onsite) Duration: Contract Job Description: Seeking an experienced Lab Systems Project Manager with 712+ years of experience managing benchtop laboratory systems implementation, integration, validation, and lifecycle management in pharmaceutical, biotech, or diagnostics environm

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Contract

Depends on Experience

GxP Project Manager (Pharma)

Hybrid in San Francisco, California

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5d 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

Loftware Spectrum Technical Lead

Remote

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Today

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

Windchill Solution Architect/Senior Windchill PLM Consultant Medical Device Industry

Remote

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6d ago

Position Title: Windchill Solution Architect/Senior Windchill PLM Consultant Experience: 12+ Years Location: Flexible / Hybrid Domain: Medical Devices (additionally we can look at candidates from Life Sciences, Healthcare domain as well but preference shall be for candidates with Medical Devices domain background) Employment Type: Full Time / Contract Position Summary We are seeking a highly experienced Windchill PLM Subject Matter Expert (SME) to lead the assessment and strategic planning for a

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Contract, Third Party

80 - 90

CQV Validation Specialist

Bend, Oregon

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Today

CQV Validation Specialist Location: Bend, OR (Onsite) Duration: 6-9 Month Contract Schedule: Full-time, onsite Interview Process: Initial Teams interview followed by a panel interview (Teams or onsite; onsite may be required). Hiring Manager Notes Immediate need due to a significant CQV validation backlog. Strong preference for candidates with analytical laboratory experience. Must be comfortable balancing priorities between CQV and Instrumentation teams. Onsite presence in Bend is requir

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Contract, Third Party

Depends on Experience

Core Java and Full Stack Application Developer QMS Developer

Sunnyvale, California

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6d ago

Job Title : Senior AI Software Engineer QMS Developer Location : Sunnyvale, CA - Fully onsite (5 days) Duration :1 year W2 Candidate Only Top Skills: Strong core Java and full-stack application development in validated GxP environments (Spring Boot, REST APIs, SQL, modern front-end framework)Python-based AI engineering LLM application and agent development (RAG, prompt engineering, orchestration, evaluation)AWS solution architecture for AI and application workloads (Bedrock/SageMaker, Lambda,

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Contract

80 - 85

Computer Systems Validation Engineer

Boston, Massachusetts

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Today

Are You Ready? CAI is a professional services company established in 1996 that has grown to more than 700 people worldwide. We provide commissioning, qualification, validation, startup, project management, and other consulting services associated with operational readiness to FDA-regulated and other mission-critical industries. Our approach is simple-we put the client's interests first, we don't stop until it's right, and we do whatever it takes to get there. Our Foundational Principles: - W

Full-time

USD 75,000.00 - 106,000.00 per year

GxP Systems Analyst, Operational Technology

North Carolina

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Today

California, US residents click here. The job details are as follows: Who We Are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs. United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop

Full-time

Technician 3 NPD Metrology, Orthopedics

Warsaw, Indiana

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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

Systems Engineering Specialist

Boulder, Colorado

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7d ago

Payrate: $54.79 - $54.79/hr Summary: As an Advanced/OT Operation & Infrastructure Professional, you will serve as the first point of contact for the Boulder site regarding any IT equipment or IT system related issues. You will collaborate with suppliers and global teams to resolve these issues efficiently. Additionally, you will be responsible for managing IT-related compliance needs and documentation for projects, ensuring all requirements are met and maintained. Responsibilities:Manage and Ma

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Contract

$54.79 - $54.79

Loftware Spectrum Technical Lead / Solution Engineer

Remote

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21d ago

At NTT DATA, we know that with the right people on board, anything is possible. The quality, integrity, and commitment of our employees have been key factors in our company's growth and market presence. By hiring the best people and helping them grow both professionally and personally, we ensure a bright future for NTT DATA and for the people who work here. For more than 25 years, NTT DATA Services have focused on impacting the core of your business operations with industry-leading outsourcing

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Contract

Depends on Experience

Digital Eng, Robotics & Automation, Process Sciences, Analytics and Technology, CGT

Los Angeles, California

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Today

We are seeking a Engineer, Digital and Data Science - Robotics and Automation within Process Sciences, Analytics and Technology, Cell and Gene Therapy. This engineer role will execute software, data, systems-integration, and digital-connectivity work required to develop and operate advanced robotic and automation platforms supporting AZD0120 and future cell and gene therapy programs. This engineer will build and support reliable interfaces, reusable software components, data pipelines, workflow

Full-time

USD 90,024.00 - 135,036.00 per year

Validation Engineer

Jersey City, New Jersey

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Today

Summary: The Validation Engineer will support GMP validation activities and equipment qualification in a pharmaceutical or life sciences environment. The role involves developing and executing Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols, reviewing validation documentation, preparing reports, and supporting deviation investigations. The engineer will ensure compliance with cGMP, GAMP, 21 CFR Part 11, Good Documentation Practices (G

Full-time

CSV Validation Engineer

Jacksonville, Florida

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Today

Summary: We are currently looking for an experienced CSV (Computer System Validation) Engineer to join our team in Plymouth, MN. Roles & Responsibilities: Develop and execute Computer System Validation (CSV) strategies, plans, protocols, and reports. Create and maintain validation documentation including URS, FS, DS, IQ, OQ, PQ, and validation summary reports. Perform risk assessments, impact assessments, traceability, and change control activities. Support validation of GxP-regulated computeri

Full-time

Sr. Computer Systems Validation Analyst

Foster, California

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Today

Summary : We are seeking a Senior Computer Systems Validation (CSV) Analyst with strong experience in GxP-regulated pharmaceutical/life sciences environments. The candidate will be responsible for planning, leading, and executing validation activities for SCADA, Rockwell FactoryTalk, PLCs, and Ignition process control systems. The role requires hands-on expertise in GAMP 5, 21 CFR Part 11, EU Annex 11, validation lifecycle documentation, risk assessments, change controls, and qualification pro

Full-time

Sr. Computer Systems Validation Analyst

Foster City, California

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Today

Full-time

CQV Engineer

Atlanta, Georgia

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Today

Summary: Seeking a CQV Validation Engineer with 5+ years of experience in pharmaceutical, biotech, or life sciences. The ideal candidate will have hands-on experience with Commissioning, Qualification & Validation (CQV) for standalone manufacturing equipment in a GMP-regulated environment. Roles & Responsibilities: Perform CQV activities for standalone equipment. uthor and execute IQ/OQ/PQ protocols, validation plans, and reports. Support FAT, SAT, commissioning, qualification, and validat

Full-time

Veeva Migration Consultant

Remote

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4d ago

We are looking for 3 strong profiles with hands-on Veeva migration experience. We need candidates who can demonstrate: Hands-on migration of clinical trial data/documents to Veeva, including source-to-target mapping, transformation, cleansing, loading, and reconciliation.Experience with regulated clinical platforms such as CTMS/eTMF/EDC and migration controls covering audit trails, metadata, data integrity, and GxP/21 CFR Part 11 expectations.Experience executing mock/test/production migration c

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Contract, Third Party

Depends on Experience

CSV Engineer

Plainfield, New Jersey

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Today

Job Title: CSV Validation Consultant - Pharma Location: Plainfield,NJ (Hybrid) Experience: 10 years Job Description: Experience in Computer System Validation (CSV) within the Pharmaceutical/Life Sciences industry. Strong knowledge of GxP, FDA 21 CFR Part 11, GAMP 5, and data integrity requirements. Experience preparing/reviewing URS, FRS, Risk Assessments, IQ/OQ/PQ, Validation Plans and Reports. Hands-on experience with validation of GxP computerized systems and related documentation. Knowledg

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