Computer System Validation (CSV) Engineer

At-a-Glance:
Are you ready to build your career by joining a certified technology solutions and compliance consulting services company? If so, our client is hiring a Computer System Validation (CSV) Engineer.

Position Type:

• Contract
• Onsite

Required:

• 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

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

Get in Touch:
We want to hear from you! If you think you’d be a good match, submit your resume and reach out to Priyanshu at (201) 478-6913 to learn more.