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