Manager, GMP Facility, Asset Readiness & HSE (Biopharmaceutical Manufacturing)

Location: Pearl River, New York, United States; onsite manufacturing environment

Company

hirify.global is an R&D-driven, AI-powered biopharmaceutical company developing medicines and vaccines for patients worldwide.

What you will do

• Maintain the manufacturing facility in a continuous GMP-ready and safety-ready state.
• Oversee GMP cleaning operations, contractor execution, cleaning records, and environmental monitoring support.
• Manage two maintenance technicians responsible for equipment asset care and readiness.
• Coordinate preventive maintenance, calibration, equipment qualification, change control, and maintenance shutdown planning.
• Lead HSE activities including safe work practices, work permits, 5S, safety walkthroughs, hazard assessments, and near-miss investigations.
• Collaborate with Maintenance, Quality, Manufacturing, and contractor teams while supporting deviations, audits, and regulatory inspections.

Requirements

• Bachelor’s degree and at least 2 years of experience in a GMP biopharmaceutical or pharmaceutical manufacturing environment.
• Experience managing facility readiness, equipment maintenance, or asset care programs.
• Experience implementing and sustaining 5S in manufacturing.
• Working knowledge of cGMP regulations, including 21 CFR Parts 210 and 211, GMP cleaning, and environmental monitoring.
• Knowledge of preventive maintenance, calibration, equipment qualification, work permitting, and HSE compliance.
• Ability to work in a manufacturing environment with cleanroom gowning, regular walking and standing, occasional lifting up to 35 lbs, and response to issues outside standard business hours.

Nice to have

• Experience in vaccine, biologics, or recombinant protein manufacturing.
• OSHA 30-hour certification or equivalent HSE training.
• Experience managing third-party cleaning or maintenance contractors.
• Knowledge of cleaning validation, Lean Manufacturing, or Six Sigma.

Culture & Benefits

• Supportive, future-focused environment centered on science and medicine delivery.
• Career growth opportunities through promotion or lateral movement, including international opportunities.
• Healthcare, prevention, wellness, and other employee benefits.
• At least 14 weeks of gender-neutral parental leave.
• Work involving digital, data, and AI-driven innovation in manufacturing and supply.