Computer System Validation (CSV) Specialist (EBR System)
Job Description
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.