Position OverviewWe are seeking an experienced
Computer System Validation (CSV) Lead with proven expertise leading and executing validation activities for
MES PAS-X implementations in regulated environments. This role will be responsible for planning, coordinating, and delivering end-to-end validation deliverables to ensure compliance with GxP, FDA, and global regulatory standards.
Key Responsibilities- Lead CSV strategy, planning, and execution for MES PAS-X implementation projects.
- Ensure compliance with GAMP 5, 21 CFR Part 11, Annex 11, and data integrity guidelines.
- Coordinate cross-functional teams (IT, Quality, Manufacturing, Vendors).
- Oversee testing execution, deviation management, and defect resolution.
- Review system configuration and ensure validation alignment with system design.
- Provide audit/inspection readiness support.
- Mentor junior validation resources and enforce documentation standards.
Required Qualifications- Bachelor's degree in Engineering, Computer Science, Life Sciences, or related field.
- 7+ years of Computer System Validation experience in regulated industries.
- 3+ years leading CSV activities for enterprise-level systems.
- Hands-on experience validating MES PAS-X platforms.
- Strong knowledge of validation lifecycle methodology and regulatory expectations.
- Demonstrated experience authoring and reviewing validation documentation.
- Excellent communication, leadership, and stakeholder management skills.
Preferred Qualifications- Experience with manufacturing execution systems in biologics or pharma production.
- Prior involvement in global or multi-site implementations.
- Familiarity with SDLC methodologies (Waterfall, Agile, Hybrid).
- Audit or regulatory inspection participation experience.
