Job Opportunities API

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.