Sr. Process Controls & Validation Engineer (Biotechnology)

Location: East Greenbush, New York, United States. Work schedule: Monday–Friday, 8:00 a.m.–4:30 p.m.; the role is performed onsite.

Salary: $67,400–$128,700 annually.

Company

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

What you will do

• Lead hands-on cGMP process validation, technology transfer, design transfer, scale-up, and process control strategy development.
• Author and execute validation protocols, reports, technical documents, and lifecycle management plans.
• Evaluate product and process risks, resolve uncertainty, and apply engineering judgment as processes move into at-scale manufacturing.
• Analyze development, characterization, and manufacturing data using statistics and engineering principles to define critical process parameters, control limits, and monitoring plans.
• Lead cross-functional discussions with Manufacturing, Quality Control, Quality Assurance, and CMC Regulatory teams.
• Support laboratory and manufacturing-scale studies, audits, inspections, and CMC regulatory submissions.

Requirements

• Bachelor’s degree in Engineering; chemical or biomedical engineering is preferred.
• 5+ years of experience for the senior level; level may be determined based on experience.
• Experience with process validation, technology transfer, and scale-up for drug substance.
• Ability to develop process control strategies and work with cGMP and ICH expectations.
• Ability to collaborate across Manufacturing, Quality, and Regulatory functions.

Culture & Benefits

• Inclusive workplace with equal employment opportunity.
• Comprehensive rewards may include bonuses, equity awards, retirement benefits, health and wellness programs, insurance, paid time off, and family support benefits.
• Onsite collaboration is emphasized for many roles.