Advanced Quality / Validation Engineer (Pharmaceuticals)

TL;DR

Advanced Quality / Validation Engineer (Pharmaceuticals): Planning and executing commissioning, qualification, and validation (CQV) activities for pharma and biotech projects with an accent on GMP compliance and quality risk management. Focus on leading CQV lifecycle documentation and serving as Project Quality Manager to ensure regulatory alignment.

Location: Clayton, NC, United States

Company

hirify.global is a global consulting firm specializing in pharmaceutical and life science project delivery.

What you will do

• Lead commissioning, qualification, and validation (CQV) activities for facilities, utilities, equipment, and computerized systems.
• Develop and review CQV lifecycle documentation, including validation plans, risk assessments, and IQ/OQ/PQ/PfV protocols.
• Serve as Project Quality Manager (PQM) for small to mid-sized projects, managing quality deliverables and strategies.
• Support FAT, SAT, startup, and commissioning activities while collaborating with engineering and automation teams.
• Provide technical guidance and act as a trusted advisor to clients on validation and compliance matters.
• Mentor junior consultants and contribute to the improvement of validation and quality best practices.

Requirements

• Bachelor's or Master's degree in Engineering, Life Sciences, Biotechnology, or a related field.
• 8+ years of experience in CQV, Quality, or Validation consulting within the pharmaceutical, biotechnology, or life sciences industry.
• Proven experience as a Quality Lead, Validation Lead, or Project Quality Manager on complex projects.
• Strong knowledge of GMP regulations (FDA, EMA, ICH), GAMP 5, ASTM E2500, and ISPE Baseline Guides.
• Must be based in or authorized to work in the United States.

Nice to have

• Experience supporting large capital projects, clean utilities, process equipment, and automation systems.
• Professional certifications such as PMP, ASQ, or ISPE.
• Previous client-facing consulting experience.

Culture & Benefits

• Competitive salary with annual adjustment increases.
• Comprehensive health, dental, and vision insurance from day one.
• 8% guaranteed 401(k) company contribution.
• 160 hours of PTO plus 14 paid holidays.
• 14 weeks of paid parental leave.
• Company-paid life and disability insurance.