Posted 3 months ago
Validation Project Lead / Documentation Audit LeadFST Technical Services · Durham
Validation Project Lead / Documentation Audit Lead
DurhamOn-siteFull-time
AI Summary
Leads documentation audit and validation activities for hygienic piping weld packages on a pharmaceutical manufacturing construction project, ensuring GMP and GDP compliance and full traceability. Manages schedules, coordinates deficiency resolution, and mentors validation specialists.
About this role
Major Pharmaceutical Facility Construction Project
Location: Durham, NC - FST Life Science office
FST Technical Services is seeking an experienced Validation Project Lead / Documentation Audit Lead to support a large pharmaceutical manufacturing facility construction project.
This role is responsible for establishing a standardized process for the validation of hygienic welding documentation (Isometrics) to ensure compliance with project specifications, applicable codes (e.g., ASME BPE), and industry best practices to support full traceability for hygienic systems..
Responsibilities
Location: Durham, NC - FST Life Science office
FST Technical Services is seeking an experienced Validation Project Lead / Documentation Audit Lead to support a large pharmaceutical manufacturing facility construction project.
This role is responsible for establishing a standardized process for the validation of hygienic welding documentation (Isometrics) to ensure compliance with project specifications, applicable codes (e.g., ASME BPE), and industry best practices to support full traceability for hygienic systems..
Responsibilities
- 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.
Required Qualifications
- 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.
Preferred Qualifications
- Experience with Traceability Matrices, ALCOA+, Equipment & Utilities Installation Qualification,
Skills
21 CFR Parts 210 & 211ALCOA+ASME BPEBluebeamCGMPCQVEIDAEquipment & Utilities Installation QualificationGood Documentation PracticesIsometricsMicrosoft OfficeSharePointTraceability Matrices
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