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.