MES PAS-X platform - CSV Lead

Position Overview We 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.

Created: 2026-03-04