21 CFR Part 11 jobs

Foster City, California

•

Today

TECHNOGEN, Inc. is a Proven Leader in providing full IT Services, Software Development and Solutions for 15 years. TECHNOGEN is a Small & Woman Owned Minority Business with GSA Advantage Certification. We have offices in VA; MD & Offshore development centers in India. We have successfully executed 100+ projects for clients ranging from small business and non-profits to Fortune 50 companies and federal, state and local agencies. Job Title: QA Test Lead Location: Foster City,CA(Onsite or Remote)

Easy Apply

Contract

$DOE

Job Title: Quality Management (QM) Consultant SAP QM | Pharmaceutical

Princeton, New Jersey

•

2d ago

Job Title: Quality Management (QM) Consultant SAP QM | PharmaceuticalLocation: Princeton, NJ (Day 1 Onsite)Duration: ContractEmployment Type: W2 Job DescriptionWe are seeking an experienced Quality Management (QM) Consultant with a strong background in SAP QM and pharmaceutical quality operations. The ideal candidate will act as a business-facing consultant, partnering with Quality Assurance (QA) and Quality Control (QC) teams to support quality processes, regulatory compliance, and SAP S/4HANA

Easy Apply

Contract

$50 - $60

Pharma IT Testing & Validation Delivery Lead

Boston, Massachusetts

•

Today

Must Have Technical/Functional Skills :8+ years in IT and Quality Assurance.5+ years supporting Pharma/Life Sciences customers.Experience leading global testing services delivery across US, UK, and India.Strong customer-facing and stakeholder management skills.Test Strategy & GovernanceFunctional, Integration, UAT, and Regression TestingData Testing & ValidationRoles & Responsibilities: Own end-to-end Testing & Validation service delivery across multiple Pharma projects Lead onsite/offshore QA t

Easy Apply

Full-time

110,000 - 130,000

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

Aliso Viejo, California

•

17d 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

Easy Apply

Contract, Third Party

Depends on Experience

POMS Techno functional SME

Albany, New York

•

11d 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

Easy Apply

Third Party, Contract

Depends on Experience

GxP Systems Engineer

Norwood, Massachusetts

•

4d ago

GxP Systems EngineerLocation: Norwood, MA (Onsite)Type: ContractClient: Moderna Job OverviewWe are seeking an experienced GxP Systems Engineer to support the design, deployment, integration, and lifecycle management of Digital Quality and laboratory automation systems within a GMP-regulated biopharmaceutical environment. The ideal candidate will have strong experience supporting analytical instrumentation, laboratory automation platforms, digital quality systems, and regulated validation process

Easy Apply

Contract

Depends on Experience

ML Platform Engineer

Remote or New York, New York

•

12d 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

Easy Apply

Contract

Depends on Experience

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

CQV Engineer

Concord, North Carolina

•

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

Staff Compliance Manager / GxP

Cambridge, Massachusetts

•

Today

A commercial SaaS company that works in the biotech and medtech space is looking for a Staff level Compliance Manager to come in and ensure their software products are in FDA, HIPPA, ISO, SOC, etc compliance. You'll ensure that their validation processes are aligned with their software products, handled product release management oversight, and be responsible for the organization's compliance frameworks. Ideal candidates have experience with 21 CFR Part 11 and EU Annexx 11, as well as have devel

Easy Apply

Full-time

$170000 - $190000

CSV Engineer

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

CSV Engineer

New Jersey

•

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

Senior OT Cybersecurity & CRA Compliance Architect

Hybrid in Dallas, Texas

•

11d 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

Computer System Validation Engineer

Bothell, Washington

•

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

Sr. CSV Engineer

Chesterbrook, Pennsylvania

•

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

Seattle, Washington

•

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

Cincinnati, Ohio

•

Today

Full-time

CSV Engineer

Columbus, Ohio

•

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

Senior OT (Operational Technology) Cyber Security Architect

Hybrid in Bedford, Texas

•

13d ago

Job DescriptionWe are looking for an experienced OT Security Architect with 12+ years of IT experience and 810 years of OT/ICS Security experience. Required SkillsStrong experience with Rockwell PLC (ControlLogix/CompactLogix).Hands-on experience with Ignition SCADA.Knowledge of OT Security, Industrial Control Systems (ICS), and the Purdue Model.Experience with EU Cyber Resilience Act (CRA), IEC 62443/ISA99, ISA 95, GMP, and FDA 21 CFR Part 11.Experience with OT risk assessments, threat modeling

Easy Apply

Third Party, Contract

Depends on Experience

Veeva Vault Analyst / Veeva Systems Administrator (CTMS & eTMF)

Remote

•

2d ago

Veeva Vault Analyst / Veeva Systems Administrator (CTMS & eTMF) Remote Duration: 6-12 months Job Summary We are seeking an experienced Veeva Vault Analyst / Veeva Systems Administrator with strong expertise in Veeva Vault Clinical Suite, specifically CTMS (Clinical Trial Management System) and eTMF (Electronic Trial Master File). The ideal candidate will be responsible for administering, configuring, supporting, and optimizing Veeva Vault applications while collaborating with clin

Easy Apply

Contract, Third Party

Depends on Experience

Filter Results

Job post features

Posted date

Work settings

Employment type

Distance

Employer type

Work authorization

21 CFR Part 11 jobs