Validation Project Lead / Documentation Audit Lead
FST Technical Services
Job Description
Job Description
Validation Project Lead / Documentation Audit Lead Major Pharmaceutical Facility Construction Project
Location: Durham, NC - FST Life Science office
- Lead documentation audit activities to ensure full traceability of hygienic piping systems.
- Manage schedule, priorities, milestones, and deliverables.
- Audit weld documentation packages for GMP and Good Documentation Practices (GDP) compliance.
- Ensure document traceability.
- Coordinate resolution of documentation deficiencies and quality observations.
- Partner with Construction Management, Fabricators and Client representatives.
- Maintain validation metrics and documentation status reports.
- Mentor junior validation specialists and documentation specialists.
- Bachelor's degree in Engineering, Life Sciences, Biotechnology, Pharmaceutical Sciences, or related technical discipline (or equivalent experience).
- 8+ years of pharmaceutical validation, CQV, QA, or GMP documentation experience.
- 3+ years leading validation documentation or CQV teams on large pharmaceutical capital projects.
- Strong knowledge of FDA cGMP regulations (21 CFR Parts 210 & 211).
- Thorough understanding of Good Documentation Practices (GDP).
- Experience supporting Commissioning, Qualification & Validation activities.
- Experience preparing projects for client and regulatory audits.
- Excellent project management, organization, and communication skills.
- Experience with Traceability Matrices, ALCOA+, Equipment & Utilities Installation Qualification,
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