21 CFR Part 11 jobs

SAP S/4HANA Validation SME Life Sciences / Pharma @ Foster City, CA _ Hybrid - Only on W2

Hybrid in Foster City, California

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Today

SAP S/4HANA Validation SME Life Sciences / PharmaLocation: Foster City, CA _ HybridExperience: 10+ YearsDomain: Life Sciences & Pharma JD: 10+ years of experience in SAP validation / CSV, preferably within Life Sciences/Pharma.Strong experience validating SAP ECC and SAP S/4HANA applications.Experience creating, reviewing, and approving validation deliverables.Strong knowledge of CSV, 21 CFR Part 11, GxP, GAMP 5, SOX IT, Data Integrity, Data Privacy, Cloud, and Information Security.Develop risk-

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Contract

$60 - $70

GxP Project Manager (Pharma)

Hybrid in San Francisco, California

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7d 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

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

Hybrid in Bedford, Massachusetts

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27d 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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6d 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

IT Business System Analyst I # 26-23641

Hollywood, Florida

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4d ago

Duration: 14 months with possible extension Overview The IT Support Analyst will support local IT applications and serve as a key connection between IT and business operations within a pharmaceutical environment. This role will help manage applications, support validation activities, translate business needs into practical technical solutions, and collaborate with local and global teams to improve efficiency while meeting quality and regulatory requirements. Responsibilities Application Support

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Contract

$42 - $44

Manufacturing Data Strategy & Architecture Consultant

Remote

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Yesterday

Job title: Manufacturing Data Strategy & Architecture Consultant Location: Remote Position Overview Seeking a senior Manufacturing Data Strategy & Architecture Consultant to support the development of a future-state data vision, strategy, and architecture roadmap. The ideal candidate will bring deep expertise in pharmaceutical manufacturing data ecosystems, industrial data architectures, contextualization, semantics, and GxP-regulated environments. This role will serve as a trusted advisor to Pf

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Full-time, Third Party

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

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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5d 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, Third Party, Contract

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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3d ago

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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3d ago

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 valid

Full-time

CQV Engineer

Portland, Maine

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3d ago

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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3d ago

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, California

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3d ago

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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3d ago

Full-time

CSV Lead Consultant at Princeton, NJ (Hybrid, 3 days in Office) || W2 Only

Hybrid in New Jersey

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Today

CSV Lead Consultant Princeton, NJ (Hybrid, 3 days in Office) Long Term Contract Mandatory Skills- Computer System Validation (CSV), GxP Systems & Compliance, Manufacturing Domain Knowledge, Labeling Systems Knowledge, Validation Testing (IQ/OQ/PQ) , Validation Documentation , FDA 21 CFR Part 11 / GAMP5 , Risk Assessment & Change Control , Stakeholder Management , Audit & Inspection Support Role Summary We are seeking an experienced Computer System Validation (CSV) Professional with strong exper

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Contract

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

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

GXP Lab Support Engineer

Hybrid in Waltham, Massachusetts

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25d 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