21 CFR Part 11 jobs

Hybrid in San Francisco, California

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12d 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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Contract, Third Party

$80 - $90

CSV Validation Lead

Hybrid in Raritan, New Jersey

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24d 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

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

Hybrid in Bedford, Massachusetts

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20d 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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24d 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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Third Party, Contract

Depends on Experience

Sr. IT Project Manager

Remote

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Today

We are seeking a Senior IT Project Manager with demonstrated experience leading complex, cross-functional technology initiatives in global and regulated manufacturing environments. The immediate priority for this role will be the delivery of projects involving Manufacturing Execution Systems, with a primary focus on the Critical Manufacturing MES platform. The successful candidate should also bring experience that can be applied across adjacent enterprise technology domains, such as SAP/ERP,

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Contract

60 - 65

Quality Data Management Analyst

Burlington, Massachusetts

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21d 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

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

DeltaV Automation Engineer (Biotech/Pharmaceutical)

Raleigh, North Carolina

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2d ago

Title: DeltaV Automation Engineer (Biotech/Pharmaceutical) Location - Raleigh - Durham NC Various years of experience: 3 - 7 years /7 - 14 years/14+ years Candidates need to be local or willing to relocate to the areas of operation where we have open opportunities for immediate hire in the Raleigh - Durham NC area: Mandatory Skills: 3+ years of work experience with Emerson DeltaV 3+ years of work experience with DeltaV Responsibilities Design, configuration, integration and implementation of pr

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

Clinical Data Business Analyst

Alameda, California

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2d ago

Clinical Data Business Analyst Biometrics & Data Engineering Role Overview This role is the connective tissue between Biometrics and Data Engineering. It exists because clinical data has meaning that structure alone doesn t carry: someone has to understand what the data represents clinically, what the standards require of it, and how it must therefore be modeled and then make sure the engineering team builds systems that produce it correctly. The SME owns that translation. They bring clinical

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Contract, Third Party

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

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

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. Author and execute IQ/OQ/PQ protocols, validation plans, and reports. Support FAT, SAT, commissioning, qualification, and val

Full-time

CSV Validation Engineer

Plymouth, Minnesota

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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 compu

Full-time

Sr. Computer Systems Validation Analyst

Foster City, 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 prot

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

Chromeleon System Administrator

Cincinnati, Ohio

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Today

Role: Chromeleon System Administrator (L2/L3) Location: Cincinnati, OH (Onsite) Start: Immediate Type: Contract Interview: Phone/Video Summary: Provide L2/L3 support, development, and integration for Chromeleon CDS applications in pharma/life sciences. Work includes SDK customization, SQL/database development, system integration, incident resolution, and GxP compliance. Skills: Chromeleon CDS / Chromeleon SDK SQL (TSQL, Stored Procedures) LIMS Integration, REST APIs C#, .NET Framework/.NET C

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Contract, Third Party

USD DOE

MES Project Manager

Remote

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3d ago

Managing, planning and execution of complex global IT projects across manufacturing and enterprise application domains, with an immediate focus on Critical Manufacturing MES initiatives. Coordinate integrations between MES and adjacent platforms, including SAP/ERP, Quality Systems, PLM, warehouse applications, automation solutions, and data platforms. Oversee validation planning and compliance deliverables in accordance with applicable FDA, GxP, and 21 CFR Part 11 requirements. Coordinate cross-

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Contract, Third Party

Depends on Experience

Lead LIMS Developer (SAPIO/LabVantage & Java)

Remote

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5d ago

Lead LIMS Developer (SAPIO/LabVantage & Java)Remote Full Time OverviewLead the architecture, development, and modernization of enterprise LIMS platforms using SAPIO/LabVantage, Java, and cloud technologies. Partner with laboratory and healthcare stakeholders to deliver scalable, secure, and compliant solutions. Key Responsibilities Lead architecture, design, development, and implementation of SAPIO LIMS and/or LabVantage.Translate laboratory requirements into workflows, integrations, and data mo

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Full-time

Depends on Experience

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

Lab Support IT Administrator

Wilmington, Ohio

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Today

WERE HIRING | LAB IT + GxP COMPLIANCE EXPERT Looking for an experienced Lab Support IT Administrator who can manage regulated laboratory systems while ensuring GxP compliance, data integrity. Wilmington, OH 45177 | Onsite Contract: 6+ Months Key Requirements: GxP / GMP / GLP / Google Cloud Platform Compliance CSV | FDA 21 CFR Part 11 | EU Annex 11 | GAMP 5 | ALCOA+ Windows, Active Directory & Advanced GPO Laboratory Systems & Instrument Support Cybersecurity & Vulnerability Management T

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Contract

Depends on Experience