Manager, GMP Facility, Asset Readiness & HSE (Biopharma)

Location: Pearl River, New York, United States; onsite manufacturing environment with cleanroom gowning, regular facility inspections, and occasional response to issues outside standard business hours.

Salary: $78,000–$112,666.66 per year.

Company

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

What you will do

• Lead GMP facility readiness, cleaning operations, facility walkthroughs, environmental monitoring support, and remediation of GMP and safety deficiencies.
• Manage two asset-care maintenance technicians and ensure manufacturing equipment is clean, calibrated, and current with preventive maintenance schedules.
• Partner with Maintenance on scope, planning, execution of shutdowns, equipment reliability, qualification activities, and change control.
• Lead HSE activities covering safe work practices, work permitting, 5S implementation, hazard assessments, safety walkthroughs, and near-miss investigations; HSE activities comprise 25–50% of the role.
• Collaborate with Maintenance, Quality, Manufacturing, and cleaning contractors; support deviation investigations, regulatory inspections, and internal audits.

Requirements

• Bachelor’s degree.
• At least 2 years of experience in a GMP-regulated environment, including biopharmaceutical, pharmaceutical, medical device/combination product manufacturing, or a related setting.
• Experience managing facility readiness, equipment maintenance, or asset care programs.
• Experience implementing and sustaining 5S methodology in a manufacturing environment.
• Experience coordinating with maintenance teams and/or third-party contractors.
• Familiarity with HSE programs, including safe work practices, permitting, and safety compliance.
• Working knowledge of cGMP regulations, including 21 CFR Parts 210 and 211, GMP cleaning requirements, environmental monitoring, preventive maintenance, calibration, equipment qualification, work permitting, and HSE compliance.
• Strong attention to detail, proactive problem-solving, facility management, leadership, team development, communication, cross-functional collaboration, prioritization, and continuous improvement skills.
• Ability to work in a manufacturing environment with cleanroom gowning, walk and stand during inspections and shopfloor activities, occasionally lift up to 35 lbs, and respond to facility or equipment 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 principles.
• Lean Manufacturing or Six Sigma training.

Culture & Benefits

• Supportive, future-focused environment centered on improving medicines and vaccine delivery.
• Career growth opportunities through promotion or lateral moves, including international opportunities.
• Rewards package and employee benefit programs.
• Healthcare, prevention and wellness programs, and at least 14 weeks of gender-neutral parental leave.
• Work focused on digital, data, and AI-driven innovation and resilient global supply.