Principal QA Validation Specialist, Fill Finish

Location: Rensselaer, New York, United States. Onsite Monday–Friday, 8:00 a.m.–4:30 p.m.

Salary: $92,200–$150,600 annually

Company

hirify.global is a biotechnology company that invents, develops, and commercializes medicines for serious diseases.

What you will do

• Lead validation activities and serve as the subject-matter expert for utilities and environmental qualification.
• Plan and execute cleanroom qualification and requalification, including environmental performance qualification for filling-line clean-air equipment.
• Qualify critical utilities such as water for injection, pharmaceutical air, air-handling units, clean steam generators, and nitrogen distribution systems.
• Lead contamination-event investigations, HACCP assessments, quality risk management deliverables, and continuous trending and reporting.
• Review change controls, CAPAs, notices of events, and qualification documents; lead audits and support inspection readiness.
• Manage and develop a specialist and consultant team while establishing compliant validation processes and supporting Annex 1 gap assessments.

Requirements

• BS or BA in Engineering, Chemistry, or Life Sciences.
• 8+ years of relevant experience in a cGMP-regulated environment.
• Experience with utility and facility qualification or validation.
• Demonstrated experience with validation, inspections, and audit readiness.
• Strong cross-functional collaboration and communication skills.
• Ability to work onsite in Rensselaer, New York, and wear full cleanroom attire, including required protective equipment and sanitizing agents.

Culture & Benefits

• Inclusive workplace and equal employment opportunity commitment.
• Potential benefits include bonuses or incentive plans, equity awards, retirement benefits, 401(k) matching, health and wellness programs, insurance, paid time off, and family support benefits.
• Reasonable accommodations are available during the recruitment process where required.