21 CFR Part 11 jobs

Validation Tester - CFR Part 11 Compliance

Hybrid in Farmingdale, New York

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Today

Please email me your resumes @ ()or call me on my cell . Job Title: Validation Tester - CFR Part 11 Compliance Location: Farmingdale, NY 3 days in office. Duration: 6-12 months About the Role Enzo Life Sciences seeks an experienced Validation Tester to execute CFR Part 11 compliance testing supporting FDA approval processes for key pharmaceutical clients including Vertex. This hybrid position requires proven life sciences validation experience with immediate availability to begin certificatio

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Third Party, Contract

Depends on Experience

NPS Validation Engineer

Plano, Texas

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5d ago

Hi, Hope you are doing well. We have the position below.Position: NPS Validation Engineer NMD Location: Plano TX Long Term We are seeking a detail-oriented Non-Product Software (NPS) Validation Engineer to join our medical technology team. This role is responsible for ensuring that all non-product software systems used in our quality management system processes comply with ISO 13485 standards and applicable regulatory requirements. The ideal candidate will have strong technical skills combine

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Contract

35+

Systems Administrator / Technical Lead -Process Control Systems

Foster City, California

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6d ago

About Nexinfo: NexInfo is a consulting firm focused on improving business processes and automation in the Supply Chain and Product Lifecycle Management sectors. They offer services in business process design, software implementations, managed services, staff augmentation, and SaaS solutions. The company aims to help businesses across industries achieve their goals through industry best practices, lean process design, and advanced software solutions. Their ERP-related services address challenges

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Contract, Third Party

$70 - $80

Senior Computerized System Validation (CSV) Manager

Remote

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6d ago

We are Looking for a Senior Computerized System Validation (CSV) Manager. 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, and compliant. You will be res

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Full-time

Depends on Experience

Clinical Data Specialist

Hartford, Connecticut

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Today

Responsibilities: Reporting to the Clinical Data Manager, you'll be responsible for the development of real-world data variables from structured and unstructured data sources, including designing data capture forms and supplemental procedures to instruct the abstraction process You'll lead the execution of feasibility testing to de-risk data capture approaches, and own the implementation of data validation checks to ensure data quality In addition, you'll work alongside other team members on way

Full-time

Clinical Data Specialist

Austin, Texas

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Today

Full-time

Sr. IT QC Specialist

Remote

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10d ago

Job Title: Senior IT Quality Control Specialist CSV/CSA Location: 100% Remote (CST preferred) Hours/Schedule: MondayFriday, standard business hours Compensation: $43-47/hour DOQ Type: Contract (12 months) OverviewThe Senior IT Quality Control Specialist provides QA oversight for computerized systems validation (CSV), remediation initiatives, and software quality processes within a regulated environment. This role ensures compliance with FDA CSA principles, GxP requirements, and global regulator

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Contract, Third Party

$47.5

Associate Director, External Data Management

Remote or Warren, Michigan

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Today

The Associate Director, External Data Services, plays a critical leadership role, overseeing team members to ensure all activities align with Regeneron's procedures and industry best practices. This position collaborates closely with Clinical Data Management teams and External Data Vendors to deliver structured external data in compliance with Regeneron SOPs. The role also involves coaching, mentoring, and managing the performance of direct reports, while contributing to the department's strateg

Full-time

USD 157,200.00 - 256,600.00 per year

Mgr Clinical Database Development

Tarrytown, New York

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Today

Manager, Clinical Database Development (Tarrytown, NY) Regeneron Pharmaceuticals, Inc. seeks a Manager, Clinical Database Development (Tarrytown, NY) to oversee the development and/or technical activities for EDC databases built by CRO partners for assigned studies. Ensure all database build activities are performed according to Regeneron Processes (or CRO processes where applicable). Contribute to the creation of CDASH compliant eCRFs. Maintain and contribute to company standard Global Library

Full-time

USD 142,958.00 - 184,700.00 per year

Computer System Validation engineer

Vacaville, California

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Today

Summary : As a Computer System Validation (CSV) Engineer specializing in the pharmaceutical industry, you will ensure that computer-based systems such as Manufacturing Execution Systems (MES), process control software, and automation platforms comply with GxP, FDA 21 CFR Part 11, EU Annex 11, and other applicable regulations. Roles & Responsibilities: Develop, execute, and review validation deliverables, including Validation Plans, User Requirements Specifications (URS), IQ/OQ/PQ protocols, and

Full-time

Validation Engineer

Dublin, Ohio

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Today

Summary : We are currently hiring multiple Validation Engineers for a pharmaceutical company that develops, manufactures, and markets generic pharmaceutical medicines. This role supports equipment, utility, and facility validation activities while ensuring compliance with FDA and global regulatory standards. Roles & Responsibilities : Execute equipment qualification and validation activities (IQ/OQ/PQ) Support utility and facility qualification efforts Ensure compliance with GMP, GAMP 5, and 21

Full-time

Computer System Validation Engineer

Vacaville, California

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Today

Job Summary: s a Computer System Validation (CSV) Engineer in the pharmaceutical industry, this role is responsible for ensuring that computer-based systems such as Manufacturing Execution Systems (MES), process control software, and automation platforms comply with GxP, FDA 21 CFR Part 11, EU Annex 11, and other applicable regulatory requirements. Roles & Responsibilities: Develop, execute, and review validation deliverables, including Validation Plans, User Requirements Specifications (URS), I

Full-time

Data integrity Specialist

Edison, New Jersey

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Today

Job Description: Implement and maintain data integrity controls for HPLC systems (Empower, Chromeleon) in compliance with ALCOA+ principles and regulatory standards (21 CFR Part 11, Annex 11). Review audit trails, monitor user access, and perform periodic data reviews. Lead and coordinate Out-of-Specification (OOS) investigations (Phase I & II), including root cause analysis, hypothesis testing, and CAPA implementation. Perform titration-based content uniformity tests as per SOPs and pharma

Full-time

Data integrity Specialist

Edison, New Jersey

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Today

Job Summary: The Data Integrity Specialist is responsible for implementing and maintaining data integrity controls for HPLC systems (Empower, Chromeleon) in compliance with ALCOA+ principles and regulatory standards such as 21 CFR Part 11 and Annex 11. The role ensures compliance with GLP, GMP, and good documentation practices while supporting validated systems, audit readiness, and laboratory data accuracy. Roles & Responsibilities: Implement and maintain data integrity controls for HPLC s

Full-time

Delta-V Engineer

Wilson, North Carolina

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Today

Job Description: We are seeking two experienced Delta-V Engineers to join our team and work onsite. The engineers will act as owners' representatives and support the existing team. This role requires expertise in automation systems, specifically Emerson Delta V, and entails working within a biopharmaceutical or pharmaceutical manufacturing environment. Roles & Responsibilities: ct as an owner's representative onsite, supporting the team with expertise in Delta-V systems. pply knowledge of Emerso

Full-time

IT Manager/Analyst (NetSuite, SOX, biotech/pharma)

San Diego, California

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Today

Key Details: Contract - 3-6 months (possibility of extension and/or conversion) - W2 Only Requirements: 5+ years G&A/financials experience; NetSuite; SOX and 21 CFR Part 11; Biotech/Pharma industry preferred Location: Hybrid - La Jolla/Sorrento Valley area Pay: $60-110/hr DOE Role Summary: Seeking a hands-on IT Manager / Analyst to own and support business critical G&A systems in a regulated environment. This role is focused on system ownership, workflow optimization, and business partnership-no

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Contract

$60 - $110 per hour

CSV Engineer

Pittsburgh, Pennsylvania

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Today

Job Summary: CSV Engineer to support commissioning and validation activities for a newly built Cell & Gene Therapy R&D and manufacturing facility in Pittsburgh, PA. The role focuses on reviewing validation deliverables, ensuring compliance with regulatory standards (21 CFR Part 11, GAMP 5), and coordinating with commissioning teams handling facilities, utilities, MES, EMS, CMMS, and related systems. The consultant will work within environments using Kneat, Microsoft Office, and automation platfo

Full-time

MES Engineer

Indianapolis, Indiana

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Today

Job Summary : We are seeking an experienced MES Engineer with strong Pharma domain experience to support and enhance Rockwell Automation Pharma Suite (Factory Talk Production Centre) in a regulated manufacturing environment. The ideal candidate must have hands-on experience working in GxP-compliant pharmaceutical manufacturing, supporting shop-floor systems, and ensuring compliance with regulatory standards. Roles & Responsibilities : Design, configure, implement, and support Rockwell PharmaSuit

Full-time

CSV Engineer

Hillsboro, Oregon

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Today

Job Description: We are seeking an experienced Computer Systems Validation (CSV) Engineer with strong communication skills and a true consultant mindset. The ideal candidate will have solid experience in pharma validation environments and hands-on exposure to manufacturing and automation systems. Requirements: Bachelor's degree in computer science, Engineering, Life Sciences, or related field. 5+ years of experience in CSV/CSA frameworks (GAMP) within the Pharma industry. Hands-on experien

Full-time

Computer Systems Validation Engineer

San Francisco, California

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Today

Role: Computer System Validation Engineer (Hybrid- 3 days a week Onsite in San francisco CA) Bridgewater Contract: 6 months with possible extension\ Minimum 10+ Years experience required .5 year in Pharma domain Job Roles and Responsibilities: * Develop, execute, and document test protocols for system qualification, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). * Ensure that software is properly validated and compliant with intern

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

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21 CFR Part 11 jobs