21 CFR Part 11 jobs

Contract Opportunity--MES IT Coordinator/Consultant--St. Louis, MO

Aliso Viejo, California

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3d ago

Role:MESIT Coordinator/Consultant Duration: Long Term Contract Location: St. Louis, MO-Onsite The SiteMESIT Coordinator will support Manufacturing Execution System (MES) project implementation and post-go-live support at the manufacturing site level. This role will act as the key coordination point between site users, GlobalMESteams, IT, Infrastructure, ERP, offshore development/configuration teams, vendors, and implementation partners. The role requires a strong functional and technical u

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Contract, Third Party

Depends on Experience

POMS Techno functional SME

Albany, New York

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5d ago

Role name: POMS Techno functional SME Work Location Albany, New York (On Site) Duration: 12+ Months Role Overview: Role POMS Techno functional SME Experience 8 to 12 Years Domain: Life Science/Pharma & MES Location: Albany, New York (onsite candidates preferred) Job Description: Experienced POMS MES Techno-Functional SME with strong expertise in Manufacturing Execution Systems (MES) within a GxP-regulated pharmaceutical environment. The candidate will act as a bridge between business stakeho

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Contract, Third Party

Depends on Experience

Site MES IT Coordinator Site MES IT Coordinator

Greenville, South Carolina

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19d ago

Company Overview: Req ID: 377935 NTT DATA strives to hire exceptional, innovative and passionate individuals who want to grow with us. If you want to be part of an inclusive, adaptable, and forward-thinking organization, apply now. NTT DATA''s Client is currently seeking a Site MES IT Coordinator Site MES IT Coordinator to join their team in St Louis, MO., Greenville, SC., or Cincinnati, OH United States (US). Job Description: Job Title: Site MES IT Coordinator Department: Manufacturing Exec

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Contract

$55 - $62

Instrument Software Validation Analyst

Cincinnati, Ohio

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20d ago

Company Overview: Req ID: 370118 NTT DATA strives to hire exceptional, innovative and passionate individuals who want to grow with us. If you want to be part of an inclusive, adaptable, and forward-thinking organization, apply now. NTT DATA''s Client is currently seeking an Instrument Software Validation Analyst to join their team in Cincinnati, Ohio (US-OH), United States (US). Overview NTT DATA''s Client is seeking an experienced Instrument Software Validation Analyst to ensure that laborator

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Contract, Third Party

$45 - $53

Computer Systems Validation Engineer

Indianapolis, Indiana

•

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

Senior Data Architect with Integrated Data Platform Exp - W2

Remote

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26d ago

Senior Data Architect to lead the data modeling and platform design for a next-generation Integrated Data Platform (IDP) supporting a regulated medical imaging program at a global pharmaceutical and diagnostics company. This role is responsible for defining the data architecture across relational and lakehouse layers, governing the structure of versioned study-level data packages, and enabling cross-modal data access for imaging, omics, and real-world data. The architect will design for GxP comp

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Contract

Depends on Experience

Network Engineer in Pharma/Biotech Domain

Raleigh, North Carolina

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17d ago

Title: Network Engineer in Pharma/Biotech Domain Location: Raleigh, NC Duration: 6 monthsResponsibilities: Design and manage LAN/WAN, wireless, and SD-WAN infrastructure across lab, manufacturing, and corporate spacesMaintain IT/OT network segmentation between corporate/lab and manufacturing floor (process control, EMS, HVAC, cleanroom systems)Support IQ/OQ/PQ validation protocols provide network diagrams, configuration baselines, and change records for regulated systemsEnsure GMP-area network c

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Contract, Third Party

$50 - $60

Urgent need on Automation Tester with Pharma/Salesforce Marketing Cloud, CA

Foster City, California

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27d ago

VERY URGENT REQUIREMENT Job Description: Automation Tester with Salesforce Marketing Cloud Location: Foster City, CA (ONSITE) Duration: 6-12 months Automation Tester Life Sciences / Medical Affairs (GxP) We are seeking an experienced Automation Tester with strong expertise in Life Sciences / Medical Affairs systems to join our team. This role requires domain knowledge in GxP compliance, 21 CFR Part 11, and hands-on experience with Salesforce Marketing Cloud and Veeva platforms. Key Responsibi

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Contract

Depends on Experience

Cloud Engineer

Indianapolis, Indiana

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13d ago

Cloud EngineerLocation: Indianapolis, IN Hybrid Onsite 3 days, fully remote if not local Employment Type: Contract, 6 months to start ( NO C2C W2 Only) Schedule: 40 hours/week Duration: Through January 22, 2027 Pay: $92.00 - $105.00/HRPosition SummaryThe Cloud Engineer designs, implements, and maintains secure, scalable, and reliable cloud-based solutions. This role supports business objectives by optimizing cloud infrastructure, automating deployments, and ensuring cloud environments meet secur

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Third Party, Contract

$92.02

Senior Full Stack Software Engineer

New Castle, Delaware

•

Today

Overview We need your talent! Waters Corporation is currently seeking a Senior Full Stack Software Engineer to join our Global Software Engineering team. Our team understands the value of their work in the real world. As a Senior Full Stack Software Engineer in New Castle, Delaware, you'll be working on instruments that are pivotal in: Electric Cars, 3D Printing, batteries, recyclable plastics, space suits, candy that melts in your mouth and not your hands, paint that goes on smooth and dries w

Full-time

Validation Engineer II

Houston, Texas

•

Today

Location: Houston, TX Posted: June 29, 2026 Req# 6227 Quality Empower Pharmacy is a visionary healthcare company dedicated to making quality, affordable medication accessible to millions of patients nationwide. As the nation's most advanced 503A compounding pharmacy and FDA-registered 503B outsourcing facility, we're redefining what's possible in personalized medicine and pharmaceutical manufacturing. We're proud to be recognized as one of Houston's fastest-growing private companies and ranked #

Full-time

OT Cybersecurity & CRA Compliance Architect

Bedford, Massachusetts

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18d ago

OT Cybersecurity & CRA Compliance ArchitectIntroduction:The OT Cybersecurity & CRA Compliance Architect will be responsible for implementing and conducting gap assessments for the EU Cyber Resilience Act (CRA), IEC 62443/ISA99, ISA 95, GMP, URS, NFR, FS, DS, IQ, OQ, PQ, audit trails, electronic records, RBAC, SCADA, and Rockwell systems. The role will also involve developing a global OT reference architecture and ensuring compliance with GMP & FDA 21 CFR Part 11 regulations, as well as Computer

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Contract

Depends on Experience

CSV Engineer

Remote or 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

CSV Engineer

Remote or Woburn, Massachusetts

•

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

Senior OT Cybersecurity & CRA Compliance Architect

Bedford, Massachusetts

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12d ago

Job DescriptionWe are looking for a Senior OT Cybersecurity & CRA Compliance Architect with extensive experience securing Operational Technology (OT) environments within the pharmaceutical or life sciences industry. The ideal candidate will have deep expertise in EU Cyber Resilience Act (CRA), IEC 62443/ISA99, GMP compliance, FDA 21 CFR Part 11, and industrial automation platforms including Rockwell ControlLogix/CompactLogix PLCs and Ignition SCADA. Key ResponsibilitiesLead EU Cyber Resilience A

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Contract, Third Party

Depends on Experience

CQV Engineer

Austin, Texas

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Today

Job Summary: We are seeking a motivated and detail-oriented Validation / CQV Engineer to support qualification and validation activities in a regulated pharmaceutical/biotech environment. The ideal candidate will have hands-on experience in IQ/OQ execution, Computer System Validation (CSV), and validation documentation while ensuring compliance with regulatory standards including 21 CFR Part 11, ALCOA principles, and GAMP guidelines. The role involves working with laboratory systems and environm

Full-time

OT Security Architect

Hybrid in Bedford, Massachusetts

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3d ago

Job Title: OT Security ArchitectLocation: Bedford, MA (Hybrid)Duration: 6-12 Months Mandatory skills:The role focuses on Rockwell PLC (ControlLogix/CompactLogix) systems, Ignition SCADA, and compliance with EU Cyber Resilience Act (CRA), IEC 62443/ISA99, ISA 95, GMP, and FDA 21 CFR Part 11.Minimum years of experience needed in the required skills- 8-10 yearsMinimum over all work experience required 10 yearsDomain Cyber Security Any certification required - Preferred Certifications:IEC 62443 Cyb

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Contract

Depends on Experience

OT/ ICS Systems Security Architect (Rockwell PLC & Ignition SCADA)

Bedford, Massachusetts

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3d ago

Job title: OT/ ICS Syetms Security Architect (Rockwell PLC & Ignition SCADA) Work Location: Bedford, MA- 01730 (Hybrid) Duration: Long Term Must Have:The role focuses on Rockwell PLC (ControlLogix/CompactLogix) systems Ignition SCADA compliance with EU Cyber Resilience Act (CRA), IEC 62443/ISA99, ISA 95, GMP, and FDA 21 CFR Part 11. Minimum years of experience needed in the required skills- 8-10 years Minimum over all work experience required 10 years Certifications:IEC 62443 Cybersecu

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Contract, Third Party

Depends on Experience

Sr. CSV Engineer

Chesterbrook, Pennsylvania

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Today

Job Summary: Seeking a Sr. CSV Engineer with 10+ years of experience in pharmaceutical compliance, Computerized System Validation (CSV), and GxP-regulated environments. The ideal candidate should have expertise in compliance regulations including 21 CFR Part 11, GxP, GAMP 5, SOX IT, Quality Management, Document Management, and Change Management. Experience with testing tools such as Client-ALM, JIRA, X-Ray, Agile methodologies, and exposure to global delivery models is required. Roles & Res

Full-time

CSV Engineer

Pennsylvania

•

Today

Job Summary: The CSV Engineer / Validation Engineer will be responsible for ensuring computerized systems in a regulated pharmaceutical environment comply with GxP, 21 CFR Part 11, GAMP 5, EU Annex 11, ISO 9001, and SOX requirements. The role involves supporting validation activities using a risk-based approach aligned with CSA principles, ensuring systems are audit-ready, and maintaining compliance throughout the system lifecycle. The position also requires hands-on involvement in documentatio

Full-time

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21 CFR Part 11 jobs