21 CFR Part 11 jobs

Computer System Validation (CSV) Engineer

Vacaville, California

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Yesterday

Computer System Validation Location: Vacaville CA (Onsite Role) Duration: - 6 -12 Months+ Job Requirements 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. Key Responsibilities: Develop, execute, and review validation deliverable

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Contract

Depends on Experience

Process/Validation Engineer

Branchburg, New Jersey

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Today

Responsibilities: Process and Cleaning Validation Experience. Equipment Qualification (IOQ/PQ). Quality System Experience (Veeva, Track wise, Compliance Wire). Medical Device or Pharmaceutical Experience Required. Preferred Medical Device with 3-5 Years. Statistical Analysis (Minitab or JUMP). The Process/Validation Engineer is responsible for providing engineering production support including: Implementing process and technology improvements. Process and Cleaning Validation. Equipment Qualifica

Full-time

Clinical Data Specialist

Austin, Texas

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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 w

Full-time

Engineer Process Support II

Somerville, New Jersey

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Today

Responsibilities: Implementing process and technology improvements. Process and Cleaning Validation. Equipment Qualification. Collecting, monitoring, analysing, troubleshooting, and reporting manufacturing data related to performance in the areas of quality, cost, and speed/service to market. Investigating non-conformances, CAPAs, process performance drifts and implementing corrective and preventative actions. Responsible for the initiation and follow-through of the change control processes. Req

Full-time

Automation Engineer

Walkersville, Maryland

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Today

Job Description: The Automation & Operational Technology (OT) Engineer is responsible for delivering technical hands-on support for site-based automation and OT systems. This role ensures the integrity, reliability, security, and compliance of OT infrastructure and industrial automation platforms across manufacturing, utilities, quality control, and laboratory environments. Key systems supported include Environmental Monitoring Systems (EMS), Building Automation Systems (Client), Process Control

Full-time

CSV Engineer

San Francisco, California

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Today

Summary: We are looking for a skilled CSV Engineer with strong experience in Veeva systems to support validation, compliance, and implementation activities in a regulated life sciences environment. The ideal candidate will have hands-on experience working on Veeva platforms and ensuring systems meet GxP and 21 CFR Part 11 compliance. Roles & Responsibilities : Perform Computer System Validation (CSV) activities for Veeva applications. Develop and execute validation documents: URS, FRS, IQ, OQ,

Full-time

CSV Engineer

Costa Mesa, California

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Today

Roles & Responsibilities: Bachelor's degree in engineering, Computer Science, Life Sciences, or related field. 2-10+ years of experience in computerized systems validation within pharmaceutical, biotechnology, or life sciences industries. Direct experience with GxP equipment, IT systems, or manufacturing automation systems. FDA and cGMP regulations and documentation practices. GAMP 5 guidance. 21 CFR Part 11 and Annex 11. Computer system validation methodologies. Familiarity with risk-based

Full-time

Validation Engineer - GxP Systems

San Francisco, California

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Today

Responsibilities: Lead and manage CSV (Computer System Validation) for GxP systems across Quality, Manufacturing, Clinical, and Business areas. Develop and maintain validation procedures, templates, and master validation plans. Prepare and review validation documentation (plans, protocols, reports). Ensure compliance with GAMP 5, 21 CFR Part 11, and ISO 13485. Collaborate with cross-functional teams (IT, QA, Engineering, Manufacturing, Clinical). Support change control, audits, CAPA, and documen

Full-time

IT Validation Consultant

Chapel Hill, North Carolina

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Today

Responsibilities: Develop and execute IT validation activities and documentation, including protocols, test plans, and change controls. uthor validation plans, verification reports, and decommissioning documentation. Ensure compliance with internal SOPs and external regulations (21 CFR Part 11, GxP, etc). Participate in investigations of validation deviations and implement corrective actions. Support IT system lifecycle activities, including maintenance, incident management, and risk assessments

Full-time

Computer System Validation Engineer

Princeton, New Jersey

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Today

Job Description Summary: The CSV Specialist is responsible for planning, coordinating, and executing validation activities for computer systems to ensure compliance with regulatory requirements. This role involves working closely with IT, Quality Assurance, and business stakeholders to validate new and existing systems, document validation evidence, and support audits and inspections. Roles & responsibility: Knowledge on FDA Guidance's and industry Standards Develop and execute validation plan

Full-time

Kneat System Developer (Technical & Validation Focus)

Remote or Parsippany-Troy Hills, New Jersey

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Yesterday

Job Title: Kneat System Developer (Technical & Validation Focus) Location Remote/WFH Duration: 6 months+ contract Note: Need strong Kneat Development / Configuration and not a user of Kneat. Overview of the Project: You will be configuring Kneat workflows and interacting with business stakeholders. Key Responsibilities: Develop, configure, and maintain Kneat GxP Validation software. Create and manage disciplines and templates. Ensure system validation and compliance with GxP, 21 CFR Part 11,

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Third Party, Contract

SAP Security Architect- Remote , CA (W2 Only)

Remote

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3d ago

Job Tile: SAP Security Architect location: Remote Duration: 6 Months Key Responsibilities: Lead SAP Security strategy and execution across S/4HANA and integrated systems (Fiori, GRC, Ariba, BTP, SAC, etc.).Review and recommend security architecture solutions aligned with business and compliance needs.Manage and mentor a team of SAP security analysts and consultants.Conduct security workshops and drive role design, provisioning, and governance.Collaborate with IT, audit, and business stakeholde

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Contract

Depends on Experience

Veeva Migration Consultant

Remote

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22d ago

We have a below position for Veeva Migration expert for remote work, please find the JD below and let me know your interest. Title: Veeva Migration Consultant Exp: 7+ to 10 years of experience in Veeva migration and implementation activities Duration: 6-12 Months Responsibilities: Migration Work stream Lead-Veeva RIMS Implementation Key Responsibilities Migration Strategy & PlanningDefine migration scope, timelines, resources, and success metrics.Develop detailed migration plans and risk mitiga

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Third Party, Contract

Depends on Experience

IT Manufacturing Support

Piscataway, New Jersey

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Today

Summary: Support patch management, antivirus updates, and Windows/server maintenance for lab PCs and software systems in coordination with IT infrastructure teams. Demonstrated experience in tracking changes, coordinating document reviews and maintaining GxP-compliant SOPs and providing end-user training for regulated IT systems. Perform regular system health checks, monitor logs, and escalate issues to infrastructure or vendor support teams as needed. Support systems connectivity and softwa

Full-time

Validation Engineer

New Brunswick, New Jersey

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Today

Job Description: Computerized Systems Validation (CSV) position involves ensuring that GxP-regulated computer systems and software comply with current Good Manufacturing Practices (cGMP) regulations, international guidelines (like 21 CFR Part 11 and Annex 11), and company standards by validating their functionality throughout their lifecycle. Key responsibilities include developing and reviewing validation documentation (protocols, reports), performing risk and impact assessments, coordinating

Full-time

Verification Support Engineer

Louisville, Kentucky

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Today

Roles & Responsibilities: Pharmacy Verification Support engineer for a minimum of 4 years. Working knowledge of software or system validation in regulated industry like Medical Device or Pharma. Strong knowledge and experience of computerized system development life cycle (SDLC) approaches and validations strategies is required. Experience with COTS/Custom made Analytical Instrument and experience working in QC Laboratories, R&D, manufacturing/operations is required. Software Quality Engineer (S

Full-time

Sr Level CSV Engineer

North Carolina

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Today

Title: Sr. Level CSV Engineer Location: NC Exp: At least 8-12yrs THIS IS A BACKFILL Client is seeking an experienced CSV Engineer to support key validation activities at a leading pharmaceutical manufacturing site. The contractor will play a critical role in ensuring compliance with regulatory and company standards by providing validation and technical support throughout the lifecycle of various systems and processes. Qualifications: Degree: Bachelor's degree in Engineering, Computer Science

Contract, Third Party

Sr. CSV Engineer

Oregon City, California

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Today

Summary : Responsible for preparing and executing test documentation for GMP computerized systems as well as providing support in the troubleshooting of issues during test execution. You should have excellent understanding of 21 CFR Part 11, ICH standards, EMA and FDA (GxP) regulations, and GAMP methodologies. Coordinate with multi-disciplinary validation team and be responsible for the validation of automated equipment and control systems Create and modify validation documentation including but

Full-time

CSV Engineer

Bothell, Washington

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Today

Summary: Responsible for preparing and executing test documentation for GMP computerized systems as well as providing support in the troubleshooting of issues during test execution. You should have excellent understanding of 21 CFR Part 11, ICH standards, EMA and FDA (GxP) regulations, and GAMP methodologies. Coordinate with multi-disciplinary validation team and be responsible for the validation of automated equipment and control systems Create and modify validation documentation including but

Full-time

Director of Data and Biostatistics

Acton, Massachusetts

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Today

Job DescriptionJob title: Director of Data and Biostatistics Location: Massachusetts The Director of Data and Biostatistics will lead all data and statistical functions within Clinical Affairs for medical device studies. This role oversees clinical data systems, ensures data accuracy and regulatory compliance, and directs statistical analysis to support safety, efficacy, and research objectives. Key Responsibilities: Lead data management strategy for medical device clinical trials. Support study

Full-time

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21 CFR Part 11 jobs