Computer System Validation (CSV) Engineer
Hired by Matrix, Inc · Myerstown, PA · 2 wk ago
On-siteQuality AssuranceContract
About the Role
Our client is hiring a Computer System Validation (CSV) Engineer to join a certified technology solutions and compliance consulting services company.
Responsibilities
- Own the validation lifecycle for GxP-regulated computer systems
- Work directly with quality, IT, and manufacturing teams to deliver compliant, audit-ready validation packages
- Lead end-to-end validation of LIMS, ERP, and MES systems per 21 CFR Part 11 and GxP regulations
- Author, execute, and review URS, FS, Validation Plans, IQ/OQ/PQ protocols, and Summary Reports
- Manage periodic reviews and revalidation of existing validated systems
- Coordinate with system owners, vendors, and IT to define scope, timelines, and deliverables
- Apply GAMP 5 principles to classify systems and define risk-based validation strategies
- Conduct formal risk assessments including FMEA and maintain site-level risk registers
- Ensure risk controls are reflected in validation test scripts and traceability matrices
- Assess computerized systems for data integrity compliance including audit trails, access controls, and electronic records
- Evaluate and remediate 21 CFR Part 11 gaps in existing validated systems
- Support data integrity investigations and respond to related audit findings
- Serve as CSV SME during FDA, EMA, and client audits and inspections
- Author and maintain SOPs, deviations, change controls, and CAPAs for validated systems
- Stay current with 21 CFR Part 11, EU Annex 11, ICH Q9, and USP 1058 guidance
Requirements
- Bachelor's in Life Sciences, Engineering, or Computer Science
- 7 years of CSV experience in a regulated pharma or life sciences environment
- Hands-on validation experience with LIMS, ERP, or MES systems
- Strong knowledge of GAMP 5, 21 CFR Part 11, and EU Annex 11
- Ability to author complete, inspection-ready validation packages independently
- Experience conducting and documenting formal risk assessments
Preferences
- Experience validating cloud-based or SaaS systems under GAMP 5 Category 4/5
- Familiarity with Veeva Vault, Kneat, or similar electronic validation platforms
- Prior experience supporting FDA or EMA inspections in a CSV capacity
- Background in biologics, clinical manufacturing, or combination products