21 CFR Part 11 jobs

Morrisville, North Carolina

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5d ago

Skills / Experience Only for locals from NC. This a Business Analyst Clinical Data Management (CDM) only applicable for this position. Business Analysis for regulated environments (Life Sciences, Pharma, Healthcare, Clinical Data Management, Biostatistics). Proven ability to gather, document, and validate requirements; conduct workshops; create functional specifications; ensure compliance with FDA 21 CFR Part 11, GxP, HIPAA Knowledge of regulatory frameworks including 21 CFR Part 11, GxP, HIPAA,

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Full-time

Depends on Experience

Computer System Validation (CSV) Lead

Wilmington, Delaware

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4d ago

Must Have Technical/Functional Skill 810 years of experience in Computer System Validation (CSV) in regulated (GxP) environments (Pharma / Biotech / MedTech). Hands-on experience with validation deliverables: VMP/VP, URS/FS/DS, risk assessments, RTM, IQ/OQ/PQ protocols and reports. Strong knowledge of 21 CFR Part 11 and EU Annex 11; ALCOA+ data integrity principles. Experience validating SDLC/CSV across system types (e.g., LIMS, MES, QMS, ERP, DMS, Lab instruments, cloud/SaaS applications). Fami

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Full-time

100,000 - 120,000

LabVantage LIMS Instrument Integration SME / Lead Validation Engineer Instrument Integration

Boston, Massachusetts

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2d ago

LabVantage LIMS Instrument Integration SME / Lead Validation EngineerIntroduction:We are seeking an experienced LabVantage LIMS Instrument Integration SME to support the design, configuration, integration, and lifecycle management of LabVantage LIMS within a regulated GxP environment. This role will serve as a technical subject matter expert responsible for integrating laboratory instruments, instrument control systems, and enterprise applications while ensuring compliance with security, validat

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Third Party, Contract

55 - 60

Sr. Computerized System Validation (CSV) Manager

Remote

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2d ago

We are Looking for a Senior Computerized System Validation (CSV) Manager with CRO industry experience. This a full-time permanent hire position with our client. In this role you can work fully remote (anywhere in USA). In this role as a Senior Computerized System Validation (CSV) Manager, you will lead the transformation of CSV practices within the organization. In this role as a Senior Computerized System Validation (CSV) Manager you will ensure validation processes are risk-based, efficient, a

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Full-time

Depends on Experience

GxP Systems Engineer

Norwood, Massachusetts

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5d ago

GxP Systems Engineer Norwood & Marlborough, MA (Onsite) Contract Client: 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 proces

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Contract

Depends on Experience

Hiring: LabVantage LIMS Instrument Integration SME / Validation Enginee

Boston, Massachusetts

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2d ago

Title: LabVantage LIMS Instrument Integration SME / Validation Engineer Client: vertex Location: -Boston, MA (Onsite) need local Duration: 6 months (C2H) Visa: USC Moi: video Must linkdin. Must pharma client experiene Client wants people already located in the Boston area, no relocators. LabVantage LIMS Instrument Integration SME / Validation Engineer Instrument Integration Job Overview: We are seeking an experienced LabVantage LIMS Instrument Integration SME to support the design, configura

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Full-time

Depends on Experience

Validation Engineer

Lebanon, Indiana

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2d ago

Position- Senior Validation Engineer, Local Type- ONSITE Location- Lebanon, IN Visa- GC Key Responsibilities Engineering & System DesignDesign and develop BMS and automation solutions for GMP/GxP-regulated pharmaceutical, biotech, and life sciences facilities.Support critical environments including cleanrooms, laboratories, manufacturing suites, central utilities, and process support systems.Develop control strategies and automation architectures for HVAC, chilled water, steam, compressed air,

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Third Party, Contract

Depends on Experience

Software Validation Analyst

Cincinnati, Ohio

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17d ago

Job Title: Instrument Software Validation Analyst Location - Cincinnati, OH (Onsite working) Overview We are seeking an experienced Instrument Software Validation Analyst to ensure that laboratory, manufacturing, and embedded software systems operate reliably, compliantly, and in accordance with regulatory requirements (GxP/FDA/EMA). The role focuses on maintaining validated systems through structured validation processes (IQ/OQ/PQ) and serves as a bridge between technical software testing and

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Contract, Third Party

Depends on Experience

Business Analyst/PM - Clinical Data

Santa Clara, California

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17d ago

Business Analyst/PM - Clinical Data Morrisville, NC 27560 - Onsite Role - Prefer local candidates Salary Market (DOE) FTE role We are looking for a seasoned Business Analyst with experience in requirement analysis and delivery of data & analytics solutions for regulated industries (Life Sciences / Pharma). The ideal candidate will drive requirement gathering, compliance alignment, and stakeholder engagement for a GxP-compliant, cloud-native data platform on Microsoft Fabric and Azure. Success

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Full-time, Third Party

Depends on Experience

Computer System Validation Consultant with JD Edwards

Remote

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20d ago

Computer System Validation Consultant with JD Edwards KnowledgeIntroduction: As a Computer System Validation Consultant with JD Edwards knowledge, you will be responsible for ensuring that computer systems used in the life sciences domain are validated according to regulatory requirements. Your expertise in JD Edwards, CSV, GAMP, and change control will be essential in this role. Responsibilities:Should have 8+ years of experience in computer system validation in the life sciences domain.Knowled

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Contract

50 - 55

Validation Engineer

Waltham, Massachusetts

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Today

Job Summary: We are seeking a detail-oriented Validation Engineer to support validation and calibration activities for critical pharmaceutical manufacturing and sterile processing equipment. This role requires strong expertise in regulatory compliance, including GMP and 21 CFR Part 11, along with hands-on experience in equipment qualification and computerized system validation (CSV). Roles & Responsibilities: Perform validation and calibration activities for pharmaceutical manufacturing and s

Full-time

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

CSV Engineer

Indiana

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Today

Job Summary: The CSV (Computer System Validation) Engineer will be responsible for ensuring that computerized systems used in a pharmaceutical/GMP-regulated environment are validated and compliant with regulatory standards, including 21 CFR Part 11. The role requires strong expertise in GAMP 5 methodology, validation lifecycle processes, and experience with automation and control systems. This is an onsite position based in Bloomfield, Indiana. Roles & Responsibilities: Execute and manage com

Full-time

CSV Engineer

Newark, Delaware

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Today

Job Summary: We are looking for a Computer System Validation (CSV) Engineer to support our client in Newark, DE. In this role, you will be responsible for ensuring that computerised systems used in regulated environments are validated and compliant with industry standards. You will work closely with IT, Quality, and business teams to support validation activities and maintain system compliance throughout its lifecycle. Roles & Responsibilities: Lead and support CSV activities for GxP systems, in

Full-time

CSV Engineer

New Jersey

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Today

Summary : CSV Validation Engineer is responsible for authoring and executing validation test scripts to support regulated systems within a GxP life sciences environment. This role will focus on validating ERP Master Data Governance processes and Data Lake platforms, ensuring compliance with regulatory requirements and data integrity standards. Roles & Responsibilities: Author, review, and execute validation test scripts (IQ/OQ/PQ) for GxP computerized systems Support validation activities for E

Full-time

CSV Engineer

Pennsylvania

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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

Validation Engineer

Wisconsin

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Today

Summary : We are seeking an experienced Validation Engineer to support pharmaceutical manufacturing and quality operations in Washington. The ideal candidate will have hands-on experience in equipment, process, cleaning, and computerized system validation within a GMP-regulated pharmaceutical environment. This role requires strong knowledge of validation lifecycle activities, regulatory compliance, documentation, and cross-functional collaboration. Roles & Responsibilities : Execute and support

Full-time

TrackWise Architect

Boston, Massachusetts

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Today

Role Summary Solution Architect responsible for designing and governing TrackWise QMS solutions including enhancements integrations and compliancedriven implementations for regulated life sciences environments Key Responsibilities Design endtoend TrackWise QMS architecture 7x 8x 9x Digital Lead solution design for CAPA Deviation Change Control Complaints Audit Training modules Drive TrackWise configuration customization and performance optimization Define and govern integrations with SAP LI

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Third Party, Contract

CSV Validation/ Clinical

Hybrid in Independence Township, New Jersey

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4d ago

CSV Validation/ ClinicalIntroduction:As a CSV Validation/ Clinical specialist, you will be responsible for defining validation strategies for computerized systems and platforms used in the GxP space. Your role will involve creating validation deliverables, participating in user review meetings, conducting risk assessments, and effectively communicating validation activities to project teams and stakeholders. Responsibilities:Define validation strategy for computerized systems and platforms in Gx

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Full-time

Depends on Experience

Senior Computer System Validation Consultant

San Diego, California

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3d ago

We are looking for Senior Computer System Validation Consultant for our client in San Diego, CA Job Title: Senior Computer System Validation Consultant Job Location: San Diego, CA Job Type: Contract Job Overview: Pay Range: $23.98hr - $28.98hrThe role involves leading computer system validation activities across the system lifecycle, ensuring regulatory compliance, data integrity, and quality governance in a biopharmaceutical environment, including validation planning, risk management, and audi

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Contract, Third Party

Depends on Experience

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21 CFR Part 11 jobs