MES PAS-X platform - CSV Lead

Inteldot • Raritan, NJ

4d

About The Position

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.

Requirements

• 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.

Nice To Haves

• 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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level