Software Validation Senior Associate
$75,000–$85,000 year
On-siteExton, Pennsylvania, United States
Job Summary
Lead the full Computerized Systems Validation (CSV) lifecycle for GxP laboratory software, developing validation strategies, risk assessments, and SDLC documentation including URS, IQ/OQ/PQ protocols, and traceability matrices. Partner with system owners and cross-functional teams to define project scope, track milestones, and support implementations, upgrades, and change controls while ensuring compliance with FDA, GAMP, ICH, and global regulatory expectations. Serve as a subject matter expert during internal and external regulatory inspections and monitor evolving regulatory requirements to maintain an effective validation program.
Required Qualifications
- Bachelor's degree in Computer Science, Engineering, Life Sciences, or a related technical discipline (or equivalent experience)
- Minimum of 3 years of Computerized Systems Validation (CSV) experience within pharmaceutical, biotechnology, CRO, or other regulated GxP environments
- Hands-on experience developing, executing, and documenting validation protocols and software qualification activities
- Strong project management experience leading multiple validation initiatives simultaneously
- Experience preparing and maintaining SDLC validation documentation including URS, Functional Specifications, Design Specifications, Risk Assessments, IQ/OQ/PQ Protocols, Traceability Matrices, and Validation Reports
- Working knowledge of ERP, laboratory software, and computerized systems used in regulated environments
- Excellent technical writing, documentation, and communication skills
- Strong organizational, analytical, and problem-solving abilities
- Experience supporting FDA, client, or international regulatory inspections
- Experience validating laboratory systems, analytical instruments, LIMS, CDS, ELN, or other GxP computerized systems
- Knowledge of software implementation, system upgrades, and change management processes
- Computerized Systems Validation (CSV)
- GAMP 5
- ICH Guidelines
- FDA 21 CFR Part 11
- 21 CFR Parts 58, 210, and 211
- Risk-based validation methodologies
- GxP compliance requirements
- Quality Systems and Change Control processes
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.