Validation Project Lead / Documentation Audit Lead

FST Technical Services fsttechnical.com Open

Durham Full-time Senior Audit & Controls

At a glance

Senior Audit & Controls role at FST Technical Services. Durham · full-time · no salary stated · we estimate $96,940–$132,277 across the United States.

Estimated pay

FST Technical Services has not published a salary for this role. The figure below is our estimate, not theirs.

$96,940 – $132,277

What the middle half of senior audit & controls roles in the United States paid, among postings that did state a salary.

Worked out from 199 postings that stated pay, median $108,099. Last updated Oct 29, 2026.

RoleAudit & Controls

SenioritySenior

LocationDurham

EmploymentFull-time

PostedJul 30, 2026

Role brief

financeroles summary, based on the employer's posting.

What you'll do

Set up a consistent review process for hygienic-welding isometrics against project requirements and applicable codes
Direct audits of weld records, checking GMP and documentation practices while preserving piping-system traceability
Track project dates, priorities, milestones and outputs, and report validation measures and document status
Resolve record gaps and quality findings with construction managers, fabricators and client representatives
Guide junior validation and documentation specialists through the project’s audit work

What you bring

A relevant technical degree or equivalent experience, plus at least eight years in pharmaceutical validation, CQV, QA or GMP records
At least three years leading validation-documentation or CQV teams on major pharmaceutical construction projects
Strong command of FDA cGMP rules and a thorough grasp of Good Documentation Practices
Experience supporting commissioning, qualification and validation work, and preparing projects for client and regulatory audits

Who this fits

This senior role suits someone who has led validation-documentation or CQV teams on large pharmaceutical projects and can guide junior specialists. The project is based in Durham, North Carolina.

From the employer

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.