21 CFR Part 11 jobs

Foster City, California

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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)

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Contract

$DOE

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

Hybrid in Bedford, Massachusetts

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5d 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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Contract, Third Party

Depends on Experience

Pharma IT Testing & Validation Delivery Lead

Boston, Massachusetts

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14d ago

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

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Full-time

110,000 - 130,000

POMS Techno functional SME

Albany, New York

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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

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Third Party, Contract

Depends on Experience

Clinical Project Manager with RBQM, Veeva, CTMS, eTMF, EDC

Remote

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2d ago

Title: Clinical Project Manager with RBQM & Veeva Foster City, CA or Remote for people who can travel for meetings Experience Range: 10- max 22 years Writeup Skills PM with BA background and experience 6+ years of proven expertise in theclinical domain and operations, including hands-on experience with systems likeCTMS, eTMF, RBQM, and EDC. 8+ years of experience analyzing requirements, documenting findings, and ensuring effective communication and clarification with stakeholders. 6+ years of

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Full-time

Depends on Experience

Information Systems Engineer 3

Sunnyvale, California

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2d ago

Detailed Job description: Position Overview: Person will be responsible for identifying, developing and implementing software solutions. This will include working with process owners to identify continuous improvement opportunities and develop software solutions to support process effectiveness and efficiencies. Individual will also be accountable for managing projects and software throughout their respective lifecycles. Roles and Responsibilities: Directly participate

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Contract, Third Party

$88 - $88

ML Platform Engineer

Remote or New York, New York

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26d 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

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

SAP QM Consultant (Life Sciences)

Hybrid in Jersey City, New Jersey

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13d ago

Required Skills: 14+ years of SAP QM experience Strong Life Sciences/Pharma/Biotech background SAP S/4HANA experience Expertise in Quality Inspection, Quality Notifications, Batch Management, and QM integration with MM/PP Knowledge of GxP, GMP, and FDA 21 CFR Part 11

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Full-time

Depends on Experience

CSV Consultant

Hybrid in Raritan, New Jersey

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5d ago

We are seeking an experienced CSV Consultant with expertise in Computer System Validation (CSV), SAP ERP, and Generative AI/Agentic AI in a GxP-regulated environment. The ideal candidate will have strong experience validating enterprise applications while ensuring compliance with FDA and global regulatory standards. Key Responsibilities: Perform Computer System Validation (CSV) activities for SAP ERP, WMS, and enterprise applications.Develop and execute validation documentation, including Valida

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Contract

45 - 50

Staff Compliance Manager / GxP

Cambridge, Massachusetts

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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

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Full-time

$170000 - $190000

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

CSV Engineer

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

OT Security Architect

Hybrid in Bedford, Indiana

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4d ago

Job title OT Security Architect Work location - Bedford, Indiana--Hybrid Contract duration 6 months No CPT,OPT,H1B 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 years Minimum over all work experience required 10 years Domain Cyber Security Preferred Certificatio

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Contract

45 - 55

LIMS Consultant

Remote

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4d ago

LabWare LIMS Configuration & Integration Specialist (LabWare 8) Location: Thousand Oaks, CA (Remote) Long term contract Position Overview We are seeking an experienced LabWare LIMS Configuration & Integration Specialist (LabWare 8) to support the LabWare 8 upgrade for a US-based GMP laboratory environment. The ideal candidate will lead a dedicated workstream focused on implementing raw material and commercial product workflows, configuring master data, and integrating laboratory instruments wit

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Contract

Depends on Experience

Veeva Vault RegulatoryOne Business Analyst

Hybrid in Ewing Township, New Jersey

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4d ago

JobTitle: Veeva Vault RegulatoryOne Business AnalystLocation: Ewing, NJ. This role will be hybrid onsite 3 days a week- Locals or nearby Only Exp Level: 12+ years genuineWe are seeking a Technical Business Analyst to lead the strategy, roadmap, and delivery of digital solutions supportingProduct Lifecycle Management (PLM), Quality Management Systems (QMS), and Regulatoryprocesses across global R&D. This role combines product ownership with business analysis, partnering with stakeholders and tech

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Contract

50 - 52

Veeva Vault Regulatory One Business Analyst

Hybrid in Ewing Township, New Jersey

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4d ago

Job Description - Job Title: Veeva Vault Regulatory One Business Analyst Location: Ewing, NJ. This role will be hybrid onsite 3 days a week- Locals Only Exp Level: 12+ years need local with DL and Linkeidn We are seeking a Technical Business Analyst to lead the strategy, roadmap, and delivery of digital solutions supporting Product Lifecycle Management (PLM), Quality Management Systems (QMS), and Regulatory processes across global R&D. This role combines product ownership with business analysis

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Contract

$40 - $60

CSV Engineer

Cincinnati, Ohio

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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

Seattle, Washington

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Today

Full-time

Senior OT (Operational Technology) Cyber Security Architect

Hybrid in Bedford, Texas

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26d 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

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Contract, Third Party

Depends on Experience