21 CFR Part 11 jobs

Hybrid in Bedford, Massachusetts

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6d ago

Hello All, Hope you are doing great Position: OT Security Architect Location: Bedford, MA Duration: 12+ months Domain Cyber Security Job description: Define and maintain global OT reference architecture (Purdue model, zones & conduits, DMZ).Lead CRA implementation and gap assessments for OT systems.Secure and harden Rockwell PLCs and Ignition SCADA environments.Perform OT cyber risk assessments and threat modelling.Implement secure configuration baselines for servers and engineering workstation

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Contract, Third Party

$70 - $80

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

Aliso Viejo, California

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10d 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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3d 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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Third Party, Contract

Depends on Experience

Site MES IT Coordinator Site MES IT Coordinator

Greenville, South Carolina

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26d 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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27d 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

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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

Network Engineer in Pharma/Biotech Domain

Raleigh, North Carolina

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24d 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

ML Platform Engineer

Remote or New York, New York

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5d ago

Role OverviewThis role will help enable algorithm development, model packaging, model registration, reproducible execution, and governed deployment workflows across imaging datasets, Integrated Data Products, and Analysis-Ready Datasets. The role is focused on ML platform engineering, MLOps, model integration, and validation readiness rather than developing new clinical interpretation algorithms. Key ResponsibilitiesBuild and support ML / MLOps capabilities within the Global Imaging Platform.Int

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Contract

Depends on Experience

Cloud Engineer

Indianapolis, Indiana

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20d 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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Contract, Third Party

$92.02

Senior Full Stack Software Engineer

New Castle, Delaware

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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

OT Cybersecurity & CRA Compliance Architect

Bedford, Massachusetts

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25d 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

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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

Senior OT Cybersecurity & CRA Compliance Architect

Hybrid in Dallas, Texas

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4d ago

Title: Senior OT Cybersecurity & CRA Compliance Architect (Pharma - Rockwell / Ignition) Role Summary We are seeking an experienced OT Cybersecurity Architect to lead cybersecurity, cyber resilience, and regulatory compliance initiatives in a GMP-regulated pharmaceutical environment. The role focuses on Rockwell PLC (ControLogix/CompactLogix) systems, Ignition SCADA, and compliance with EU Cyber Resilience Act (CRA), IEC 62443/ISA99, ISA 95, GMP, and FDA 21 CFR Part 11. Key Responsibilities

Full-time, Third Party

Depends on Experience

Senior OT Cybersecurity & CRA Compliance Architect

Bedford, Massachusetts

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19d 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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Third Party, Contract

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

Computer System Validation Engineer

Remote or Bothell, Washington

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Today

Job Summary: We are seeking an experienced Computer System Validation (CSV) Engineer/Contractor to lead and execute validation activities for GxP computerized systems, with a strong focus on Manufacturing Execution Systems (MES) in a pharmaceutical or biologics manufacturing environment. The ideal candidate will have expertise in CSV lifecycle management, GAMP, 21 CFR Part 11, protocol development and execution, and cross-functional collaboration to ensure compliance with regulatory and quality

Full-time

CSV Engineer

Remote or Seattle, Washington

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Today

Job Description: The CSV Engineer is responsible for ensuring that GxP computerized systems at the client site are validated in compliance with regulatory standards (21 CFR Part 11, EU Annex 11, GAMP 5). This role directly supports gene therapy manufacturing operations by leading validation activities for key systems, including Veeva QMS, BMRAM, analytical lab instruments, and the Metasys Client. By maintaining data integrity and system compliance, the CSV Engineer plays a critical part in ensur

Full-time

CSV Engineer

Remote or Cincinnati, Ohio

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Today

Full-time

CSV Engineer

Columbus, Ohio

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Today

Job Summary: The CSV Engineer is responsible for ensuring that GxP computerized systems at the client site are validated in compliance with regulatory standards (21 CFR Part 11, EU Annex 11, GAMP 5). This role directly supports gene therapy manufacturing operations by leading validation activities for key systems, including Veeva QMS, BMRAM, analytical lab instruments, and the Metasys Client. By maintaining data integrity and system compliance, the CSV Engineer plays a critical part in ensuring

Full-time

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21 CFR Part 11 jobs