CQV Validation Lead: GMP Documentation Audit

FST Technical Services; Durham (NC); On-site; USD 120,000 - 180,000; Full time

Job summary

FST Technical Services is seeking an experienced Validation Project Lead / Documentation Audit Lead to support a major pharmaceutical facility construction project in Durham, NC. You will establish standardized validation processes for hygienic welding documentation (Isometrics) to ensure traceability and compliance with FDA cGMP, GDP, and project specifications.

The role requires 8+ years in pharmaceutical validation and CQV, with proven leadership of large teams, strong project management, and

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).
• Experience supporting Commissioning, Qualification & Validation activities.

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 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.

Skills

Project leadership

Documentation audit

GMP GDP knowledge

FDA cGMP knowledge

Audit coordination

Education

Bachelor's degree in Engineering/Life Sciences/Pharma

Tools

Bluebeam

Microsoft Office

SharePoint

Job description

FST Technical Services is seeking an experienced Validation Project Lead / Documentation Audit Lead to support a major pharmaceutical facility construction project in Durham, NC. You will establish standardized validation processes for hygienic welding documentation (Isometrics) to ensure traceability and compliance with FDA cGMP, GDP, and project specifications.

The role requires 8+ years in pharmaceutical validation and CQV, with proven leadership of large teams, strong project management, and