21 CFR Part 11 jobs

Hybrid in Raritan, New Jersey

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10d ago

Role CSV Validation Lead Location -Raritan, NJ(Hybrid) Job Details: 5+ years of Computer System Validation (CSV) experience in GxP-regulated environments, with hands-on experience in retro-validation activities and 21 CFR remediation projects with knowledge of CSA, GAMP 5, 21 CFR Part 11, Annex 11, and audit/inspection readiness. Experience in the Pharmaceutical, biotechnology, or medical device industry. Experience in FDA and/or Global regulated environment with good understanding of GxP standa

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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

OT Security Architect----Bedford, MA -- candidates can work for any Client office--Hybrid

Hybrid in Bedford, Massachusetts

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6d ago

OT Security Architect Bedford, MA -- candidates can work for any Client office Skills: OT--Hands on strong exp risk management pharmaceutical cyber Rockwell PL Ignition SCADA compliance with EU Cyber Resilience Act (CRA) IEC 62443/ISA99 ISA 95 GMP FDA 21 CFR Part 11 Certification--added advantage at least try for few IEC 62443 Cybersecurity Expert GICSP / CISSP Rockwell Automation Sirisha N Sr IT Analyst Humac Inc.

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Third Party, Contract

Depends on Experience

OCM Consultant - MDM

Hybrid in Fort Worth, Texas

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10d ago

Title: Organizational Change Management Consultant - MDM Location: Fort Worth, TX (Hybrid- 3days onsite in a week) Position Overview TheOCM Leadwill drive the people, process, and culture strategy for our globalMaster Data Management (MDM)transformation. In the highly regulated medical device industry, data integrity directly impacts product quality, regulatory compliance, and patient safety. This role focuses on accelerating the adoption of new data governance policies, standardized workflows,

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Contract, Third Party

Depends on Experience

CQV Validation Specialist

Bend, Oregon

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Today

CQV Validation Specialist/ CSV/CQV Specialist Location: Bend, OR (Onsite) Duration: 6-9 Month Contract 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 required to support in

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Third Party, Contract

Depends on Experience

Senior QC Technician

Oceanside, California

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Today

Description: What you will do Create automated laboratory workflows and support development of laboratory recipeswithin the Biovia software system. Collaborate with business stakeholders to gather feedback and propose new functionalities Report defects, test new software features, and support system improvements Design and enhance reporting functionalities and interfaces within laboratory systems Work with end users to design and optimize complex workflows and processes Prepare and maintai

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Contract, Third Party

$28 - $35

Clinical Project Manager with RBQM, Veeva, CTMS, eTMF, EDC

Remote

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19d ago

Title: Clinical Project Manager with RBQM & Veeva Foster City, CA or Remote for people who can travel for meetings Experience Range: 10- max 22 years Writeup Skills PM with BA background and experience 6+ years of proven expertise in theclinical domain and operations, including hands-on experience with systems likeCTMS, eTMF, RBQM, and EDC. 8+ years of experience analyzing requirements, documenting findings, and ensuring effective communication and clarification with stakeholders. 6+ years of

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Full-time

Depends on Experience

Quality Data Management Analyst

Burlington, Massachusetts

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7d ago

HonorVet Technologies is 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 is headed and only reach out when we genuinely believe there''s a fit worth exploring. Job Title: Quality Data Mana

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Contract

$48.56 - $53.36

Principal LIMS Developer- Java & Sapio

Remote

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3d ago

Job Title: Lead LIMS Developer (SAPIO/LabVantage & Java) Remote Full Time Overview Lead the technical direction of a major Laboratory Information Management System (LIMS) modernization initiative focused on designing and delivering a future-state laboratory platform. This role combines architecture, hands-on development, technical leadership, and close collaboration with laboratory and healthcare stakeholders to build scalable, compliant LIMS solutions. What You'll Do Lead the design, architectu

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Full-time

Depends on Experience

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

CQV Engineer

Portland, Maine

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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

CQV Engineer

Concord, North Carolina

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Today

Summary : Seeking a CQV Validation Engineer 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. Author and execute IQ/OQ/PQ protocols, validation plans, and reports. Support FAT, SAT, commissioning, qualification, and validation activities.

Full-time

CSV Consultant

Hybrid in Raritan, New Jersey

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27d ago

We are seeking an experienced CSV Consultant with expertise in Computer System Validation (CSV), SAP ERP, and Generative AI/Agentic AI in a GxP-regulated environment. The ideal candidate will have strong experience validating enterprise applications while ensuring compliance with FDA and global regulatory standards. Key Responsibilities: Perform Computer System Validation (CSV) activities for SAP ERP, WMS, and enterprise applications.Develop and execute validation documentation, including Valida

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Contract

45 - 50

CSV Engineer

Woburn, Massachusetts

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Today

Job Summary: We are seeking a Computer System Validation (CSV) Engineer with experience in Computer System Validation (CSV) within a GMP-regulated pharmaceutical or biotechnology environment. The ideal candidate will have expertise in GAMP 5, 21 CFR Part 11, validation lifecycle documentation, and QC laboratory or manufacturing systems validation, while collaborating with cross-functional teams to ensure regulatory compliance. Roles & Responsibilities: Develop, execute, and maintain Computer S

Full-time

CSV Engineer

New Jersey

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Today

Job Description: We are seeking a Computer System Validation (CSV) Engineer with experience in Computer System Validation (CSV) within a GMP-regulated pharmaceutical or biotechnology environment. The ideal candidate will have expertise in GAMP 5, 21 CFR Part 11, validation lifecycle documentation, and QC laboratory or manufacturing systems validation, while collaborating with cross-functional teams to ensure regulatory compliance. Roles & Responsibilities: Develop, execute, and maintain Computer

Full-time

Pharma Project manager

Hybrid in California City, California

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18d ago

Hi Job Title: Pharma Project Manager (No IT PM ) Location: California Duration : Long Term Contract Job Summary: We are seeking an experienced GxP Project Manager to lead and manage cross-functional GxP initiatives supporting pharmaceutical manufacturing, The ideal candidate will have strong experience delivering GxP-compliant projects within regulated pharmaceutical or biotechnology environments while ensuring compliance with FDA regulations, GMP, GAMP 5, and 21 CFR Part 11. Rajneesh Sing

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Contract

80 - 90

Computer System validation Engineer

Wilmington, Delaware

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Today

Hi, Title:Computer System validation Engineer Compute System Validation(CSV) with R&D Knowledge Qualification: Bachelor of Science OR Bachelor of Technology OR Bachelor's in Pharmacy Experience: Over 8+ years of overall experience with at least 5 years of experience in Computer System validation for GxP system Knowledge, Experience and Skills: { CORE CSV 21 CFR Part 11/820, GxP, GAMP 5, SOX, EU Annex 11/22, ISO 9001, ITIL, EU Anness 22, ISO 9001, ITIL, Audit/inspection readiness, periodic r

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

GXP Lab Support Engineer

Hybrid in Waltham, Massachusetts

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4d ago

We have an exciting opportunity for a GxP Lab Computing Engineer with Zifo. Position: GxP Lab Computing Engineer Client: Zifo Location: Virtual/Remote Relocation candidates considered Visa: Open to all visa types Duration: Contract Key Requirements: 5+ years of relevant experience in Lab IT/ComputingStrong experience supporting laboratory instruments and connected systemsExperience with requirements gathering, business analysis, and IT consultingHands-on troubleshooting and break/fix support for

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Full-time

Depends on Experience

Computer System Validation Engineer

Wilmington, Delaware

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Today

Roles & Responsibilities : 21 CFR Part 11/820, GxP, GAMP 5, SOX, EU Annex 11/22, ISO 9001, ITIL, EU Anness 22, ISO 9001, ITIL, Audit/inspection readiness, periodic reviews, access roster and audit trail reviews, Deviation/CAPA management, SOP/policy compliance processes uthoring of URS/FS, protocols, final reports, validation plan/report High-level understanding of Veeva Vault suits Risk-based testing aligned to CSA fundamentals High-level understanding of Biostatistics, Clinical, Discovery, Med

Full-time

IT / CSV Specialist

San Juan, San Juan

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Today

PACIV, a global leader in industrial automation solutions servicing the Life Sciences sector, is seeking a IT / CSV Specialist to provide technical support for laboratory applications, systems, infrastructure, and validation activities within a pharmaceutical manufacturing environment. Position Responsibilities / Essential Functions:Provide IT support for laboratory applications such as Empower, SmartLab, and Darwin LIMS.Perform user administration, troubleshooting, and support for laboratory s

Full-time