Job Title: Manager, GMP Facility, Asset Readiness & HSE

Location: Pearl River, NY

About the Job

Leads GMP facility readiness, equipment asset care, and HSE compliance to ensure the manufacturing shopfloor is maintained in a GMP-ready and safety-ready state at all times. Oversees GMP cleaning operations, manages two dedicated maintenance technicians for asset care, and partners with Maintenance teams on equipment PM, calibration, and shutdown planning. Dedicates 25-50% of time to HSE activities including safe work practices, 5S implementation, work permitting, and safety compliance. Ensures attention to facility details including rust, cleaning residue, paint integrity, and floor conditions while maintaining all GMP documentation and environmental monitoring requirements.

Leads GMP facility readiness, equipment asset care, and HSE compliance to ensure the manufacturing shopfloor is maintained in a GMP-ready and safety-ready state at all times. This role is accountable for facility cleanliness, equipment reliability, asset care management, and health, safety & environment compliance across all manufacturing operations.

Main Responsibilities

GMP Facility & Cleaning Operations

• Ensure the manufacturing facility is maintained in a GMP-ready and safety-ready state at all times
• Oversee and coordinate GMP cleaning operations of all manufacturing areas in compliance with cleaning procedures and validation requirements
• Partner with third-party cleaning contractor to ensure thorough execution of cleaning activities, with attention to detail including rust, cleaning residue, paint integrity, floor conditions, and other facility deficiencies
• Conduct regular facility walkthroughs to identify and remediate GMP and safety deficiencies
• Maintain cleaning logs, records, and documentation in compliance with GMP requirements
• Ensure environmental monitoring requirements are supported and met within the manufacturing facility

Equipment Asset Care & Maintenance

• Directly manage two dedicated maintenance technicians focused on asset care and equipment readiness
• Ensure all manufacturing equipment is clean, calibrated, and current with preventive maintenance (PM) schedules
• Partner with the Maintenance team to define scope of work, planning, and execution of maintenance shutdowns
• Maintain equipment status boards and asset care records to ensure full traceability and GMP compliance
• Proactively identify equipment reliability risks and drive resolution through appropriate channels
• Support equipment qualification activities (IQ/OQ/PQ) and change control processes as needed

Health, Safety & Environment (HSE) - 25-50% of Role

• Champion a culture of safety across the manufacturing shopfloor
• Ensure safe work practices are understood, followed, and reinforced among all team members and contractors
• Manage and coordinate work permitting processes (e.g., confined space, hot work, lockout/tagout)
• Lead and sustain 5S implementation and continuous improvement across manufacturing areas
• Conduct safety walkthroughs, hazard assessments, and near-miss investigations
• Ensure compliance with all applicable HSE regulations, site policies, and Sanofi standards
• Serve as a key point of contact for HSE topics on the manufacturing shopfloor

Team Leadership & Collaboration

• Lead, develop, and manage two dedicated asset care maintenance technicians
• Collaborate cross-functionally with Maintenance, Quality, and Manufacturing teams
• Coordinate with cleaning contractor management to ensure GMP and safety standards are consistently met
• Participate in deviation investigations related to facility, equipment, or cleaning deficiencies
• Support regulatory inspections and internal audits related to facility and equipment readiness

Basic Qualifications

• Bachelor's degree
• 2+ years of experience in a GMP biopharmaceutical or pharmaceutical manufacturing environment.
• Demonstrated experience managing facility readiness, equipment maintenance, or asset care programs
• Proven 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.

Technical Knowledge

• Working knowledge of cGMP regulations (21 CFR Parts 210, 211) and GMP cleaning requirements
• Understanding of environmental monitoring principles and practices in a manufacturing setting
• Knowledge of preventive maintenance, calibration programs, and equipment qualification
• Experience with 5S implementation and workplace organization
• Familiarity with work permitting systems and HSE compliance requirements

PREFERRED QUALIFICATIONS

• 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

Soft Skills

• Strong attention to detail and commitment to GMP and safety standards
• Proactive problem-solving and facility management skills
• Effective leadership and team development capabilities
• Strong communication and cross-functional collaboration skills
• Ability to manage multiple priorities in a fast-paced manufacturing environment
• Continuous improvement mindset with hands-on approach

PHYSICAL REQUIREMENTS

• Ability to work in a manufacturing environment including cleanroom gowning requirements
• Regular walking and standing during facility inspections and shopfloor activities
• Occasional lifting up to 35 lbs
• Flexibility to respond to facility or equipment issues outside of standard business hours

The salary range for this position is:
$78.000,00 - $112.666,66

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.