Advanced Validation Engineer (Pharmaceutical CQV)

Location: Clayton, North Carolina, United States. Unrestricted authorization to work in the United States is required; employer-sponsored work authorization is not available.

Company

hirify.global delivers engineering, commissioning, qualification, validation, and quality services for pharmaceutical, biotechnology, and life sciences projects.

What you will do

• Support commissioning, qualification, and validation activities for facilities, utilities, equipment, and computerized systems.
• Develop and review validation plans, risk assessments, IQ/OQ/PQ/PfV protocols, traceability matrices, and summary reports.
• Execute qualification activities, troubleshoot technical and compliance issues, and support FAT, SAT, startup, and commissioning activities.
• Align project quality strategies with client and regulatory requirements while monitoring risks, resources, budgets, and quality outcomes.
• Provide technical guidance to clients and project teams on CQV, GMP compliance, quality risk management, and validation strategy.
• Support proposals and project planning, present progress and mitigation plans, mentor junior consultants, and contribute to continuous improvement.

Requirements

• Bachelor’s or Master’s degree in Engineering, Life Sciences, Biotechnology, Pharmaceutical Sciences, or a related field.
• 5+ years of CQV, quality, validation, or GMP consulting experience in the pharmaceutical, biotechnology, or life sciences industry.
• Experience with qualification and validation programs for GMP-regulated facilities.
• Strong knowledge of GMP regulations, including FDA, EMA, and ICH requirements, as well as GAMP 5, ASTM E2500, ISPE Baseline Guides, quality risk management, data integrity, and validation lifecycle management.
• Must have unrestricted authorization to work in the United States and must not require current or future sponsorship.

Nice to have

• Experience with large capital projects, clean utilities, process equipment, facilities, and automation systems.
• PMP, ASQ, ISPE, or similar professional certification.
• Client-facing consulting experience.

Culture & Benefits

• Competitive salary with annual adjustment increases.
• 160 hours of paid time off, prorated from the hire date, plus 14 paid holidays.
• Health, dental, and vision insurance from the first day.
• 8% guaranteed 401(k) company contribution.
• 14 weeks of paid parental leave and company-paid life and disability insurance.
• Employee referral bonuses.

Hiring process

• Applications are accepted through the online application system only.
• Interviews are scheduled on a rolling basis.
• Application deadline: October 30, 2026.