Validation Project Lead / Documentation Audit Lead

FST Technical Services; North Carolina; On-site; USD 120,000 - 180,000; Full time

Job summary

FST Technical Services seeks an experienced Validation Project Lead / Documentation Audit Lead to support a large pharmaceutical facility construction project in Durham, NC. The role focuses on establishing a standardized process for validating hygienic welding documentation (Isometrics) to ensure full traceability and compliance with project specs and 21 CFR Parts 210 & 211.

You will lead GMP/GDP documentation audits, coordinate deficiencies, and partner with Construction Management,

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Biotechnology, Pharmaceutical Sciences, or related field.
• 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.

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 management

Communication

Organization

Leadership

FDA cGMP knowledge

GMP/GDP understanding

Education

Bachelor’s degree in Engineering or Life Sciences

Tools

Bluebeam

Microsoft Office

SharePoint

EIDA

Job description

Validation Project Lead / Documentation Audit Lead
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

• 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,
  Experience with EIDA, Bluebeam, Microsoft Office and SharePoint.