21 CFR Part 11 jobs

Hybrid in Raritan, New Jersey

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3d ago

Role CSV Validation Lead Location -Raritan, NJ(Hybrid) Job Details: 5+ years of Computer System Validation (CSV) experience in GxP-regulated environments, with hands-on experience in retro-validation activities and 21 CFR remediation projects with knowledge of CSA, GAMP 5, 21 CFR Part 11, Annex 11, and audit/inspection readiness. Experience in the Pharmaceutical, biotechnology, or medical device industry. Experience in FDA and/or Global regulated environment with good understanding of GxP standa

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Contract

Depends on Experience

GxP Project Manager (Pharma)

Hybrid in San Francisco, California

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4d 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

Lab Support IT Administrator

Wilmington, Ohio

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3d ago

Employment Eligibility Statement: Due to specific project and client requirements, this position is open to U.S. Citizens and U.S. Lawful Permanent Residents (Green Card holders). Sponsorship is not available at this time. Danta Technologies evaluates all candidates in compliance with the Immigration and Nationality Act (INA) and EEOC guidelines. All hiring decisions are made without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, vete

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Contract

$28 - $30

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

Hybrid in Bedford, Massachusetts

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18d 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

OCM Consultant - MDM

Hybrid in Fort Worth, Texas

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3d 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

CQV Validation Specialist

Bend, Oregon

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2d ago

CQV Validation Specialist/ CSV/CQV Specialist Location: Bend, OR (Onsite) Duration: 6-9 Month Contract Interview Process: Initial Teams interview followed by a panel interview (Teams or onsite; onsite may be required). Hiring Manager Notes Immediate need due to a significant CQV validation backlog.Strong preference for candidates with analytical laboratory experience.Must be comfortable balancing priorities between CQV and Instrumentation teams.Onsite presence in Bend is required to support in

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Third Party, Contract

Depends on Experience

Pharma IT Testing & Validation Delivery Lead

Boston, Massachusetts

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28d 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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25d 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

Senior QC Technician

Oceanside, California

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2d ago

Description: What you will do Create automated laboratory workflows and support development of laboratory recipeswithin the Biovia software system. Collaborate with business stakeholders to gather feedback and propose new functionalities Report defects, test new software features, and support system improvements Design and enhance reporting functionalities and interfaces within laboratory systems Work with end users to design and optimize complex workflows and processes Prepare and maintai

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Contract, Third Party

$28 - $35

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

Remote

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11d 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

CQV Engineer

Portland, Maine

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Today

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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Today

Full-time

SAP QM Consultant (Life Sciences)

Hybrid in Jersey City, New Jersey

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27d 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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19d 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

Pharma Project manager

Hybrid in California City, California

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10d ago

Hi Job Title: Pharma Project Manager (No IT PM ) Location: California Duration : Long Term Contract Job Summary: We are seeking an experienced GxP Project Manager to lead and manage cross-functional GxP initiatives supporting pharmaceutical manufacturing, The ideal candidate will have strong experience delivering GxP-compliant projects within regulated pharmaceutical or biotechnology environments while ensuring compliance with FDA regulations, GMP, GAMP 5, and 21 CFR Part 11. Rajneesh Sing

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Contract

80 - 90

Computer System validation Engineer

Wilmington, Delaware

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Today

Hi, Title:Computer System validation Engineer Compute System Validation(CSV) with R&D Knowledge Qualification: Bachelor of Science OR Bachelor of Technology OR Bachelor's in Pharmacy Experience: Over 8+ years of overall experience with at least 5 years of experience in Computer System validation for GxP system Knowledge, Experience and Skills: { CORE CSV 21 CFR Part 11/820, GxP, GAMP 5, SOX, EU Annex 11/22, ISO 9001, ITIL, EU Anness 22, ISO 9001, ITIL, Audit/inspection readiness, periodic r

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

Computer System Validation Engineer

Wilmington, Delaware

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Today

Roles & Responsibilities : 21 CFR Part 11/820, GxP, GAMP 5, SOX, EU Annex 11/22, ISO 9001, ITIL, EU Anness 22, ISO 9001, ITIL, Audit/inspection readiness, periodic reviews, access roster and audit trail reviews, Deviation/CAPA management, SOP/policy compliance processes uthoring of URS/FS, protocols, final reports, validation plan/report High-level understanding of Veeva Vault suits Risk-based testing aligned to CSA fundamentals High-level understanding of Biostatistics, Clinical, Discovery, Med

Full-time