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21 Cfr Part 11 Validation Jobs (NOW HIRING)

Validation & Engineering Group, Inc

PR

Validate and support the Electronic Batch Record / EVRS implementation so it meets 21 CFR Part 11, EU GMP Annex 11, GxP, and company quality requirements. Scope of work: * Develop/execute CSV ...

Mirus Consulting Group

CSV Specialist

Gurabo, PR · On-site

... validation lifecycle, ensuring compliance with FDA, cGMP, 21 CFR Part 11, GAMP 5, and corporate standards. This position will support system implementations, upgrades, and periodic reviews across ...

Mirus Consulting Group

CSV Specialist

Gurabo, PR · On-site

... validation lifecycle, ensuring compliance with FDA, cGMP, 21 CFR Part 11, GAMP 5, and corporate standards. This position will support system implementations, upgrades, and periodic reviews across ...

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21 Cfr Part 11 Validation information

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How much do 21 cfr part 11 validation jobs pay per hour?

As of Aug 9, 2026, the average hourly pay for 21 cfr part 11 validation in the United States is $52.00, according to ZipRecruiter salary data. Most workers in this role earn between $39.42 and $63.22 per hour, depending on experience, location, and employer.

What is 21 CFR Part 11 Validation?

A 21 CFR Part 11 Validation job involves ensuring that electronic records and signatures comply with FDA regulations for reliability, security, and data integrity. Professionals in this role validate computer systems, software, and processes used in regulated industries like pharmaceuticals and biotechnology. They create and execute validation protocols, conduct risk assessments, and document compliance efforts. Their work helps organizations meet regulatory requirements and avoid issues related to electronic data integrity.

What skills and qualifications are needed for 21 CFR Part 11 Validation?

To thrive in a 21 CFR Part 11 Validation role, you need in-depth knowledge of FDA regulations, validation protocols, and quality compliance standards, often supported by a degree in life sciences, engineering, or a related field. Experience with computerized systems validation (CSV) tools, risk management methodologies, and familiarity with common validation documentation systems is highly valuable, and certifications such as ASQ or PMP can be an advantage. Strong analytical thinking, attention to detail, and effective communication skills are crucial for preparing documentation and collaborating with cross-functional teams. These capabilities enable accurate validation processes, ensure regulatory compliance, and minimize risks in regulated environments.

What are the common challenges faced in 21 CFR Part 11 Validation?

One of the common challenges in a 21 CFR Part 11 Validation role is keeping up with evolving regulatory requirements while ensuring all computerized systems meet compliance standards. You'll often need to manage multiple projects simultaneously, coordinate with IT, QA, and production teams, and address any gaps in existing processes or documentation. Additionally, troubleshooting integration issues between systems and maintaining meticulous records can require both technical expertise and organized workflows. Overcoming these challenges not only enhances your problem-solving skills but also strengthens your value as a validation professional.

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21 Cfr Part 11 Validation jobs near you
Infographic showing various 21 Cfr Part 11 Validation job openings in the United States as of August 2026, with employment types broken down into 98% Full Time, and 2% Part Time. Highlights an 99% Physical, and 1% Remote job distribution, with an average salary of $108,152 per year, or $52 per hour.

Computer System Validation (CSV) Specialist (EBR System)

Validation & Engineering Group, Inc

PR

Full-time

Posted 18 days ago

Job description

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethical standards for the following position:

  • Computer System Validation (CSV) Specialist

Project summary:

  • Validate and support the Electronic Batch Record / EVRS implementation so it meets 21 CFR Part 11, EU GMP Annex 11, GxP, and company quality requirements.

Scope of work:

  • Develop/execute CSV deliverables for EVRS modules that manage recipes (formulas), master batch records, and batch execution.
  • Confirm system requirements, risk assessment, and traceability for recipe data, electronic signatures, audit trails, and change control.
  • Perform vendor/system assessments, GAP analysis, and mapping to regulatory controls.
  • Create/execute validation artifacts: URS, VRA, FRS/SRS (if applicable), DQ/IQ/OQ/PQ (or equivalent), test scripts, test execution results, traceability matrix, validation summary report.
  • Support configuration, data migration/verification of recipe records, user acceptance testing, and remediation/defect closure.
  • Provide CSV support during go-live and initial production batches, and handover to QA/IT for periodic review.

Deliverables:

  • Validation project plan and schedule
  • Requirements traceability matrix (RTM)
  • Risk assessment (e.g., FMEA/Hazard analysis for recipes)
  • Design qualification (DQ) report
  • Installation qualification (IQ) procedures & reports
  • Operational qualification (OQ) procedures & reports (including negative/edge cases for recipe execution)
  • Performance qualification (PQ) scripts & reports (including sample batch runs)
  • Test scripts and executed test evidence, incl. electronic signature and audit trail verification
  • Data migration plan and verification evidence for recipe/master records
  • Validation summary report and final sign-off package
  • SOP/Work instruction reviews and CSV-related training materials
  • Post-implementation validation support

Resource profile / qualifications:

  • CSV specialist with 5+ years experience validating EBR/EVRS systems in regulated pharma/biotech/medical devices.
  • Experience with 21 CFR Part 11, EU Annex 11, GMP, and applicable GCP/GLP as needed.
  • Hands-on experience writing/executing IQ/OQ/PQ and creating traceability matrices.
  • Experience with recipe management, MES/SCADA/ERP integrations, and data migration for master recipes.

Preferred:

  • Computer science/engineering or life-science degree; certification(s) such as ASQ, ISPE, or vendor-specific EVRS experience.
  • Available to work additional hours and weeks-ends if required at certain time
  • First shift project
  • On site project

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.
Excited to build something meaningful together? We look forward to hearing from you.
Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.