Manager, GMP Facility and HSE Readiness

Sanofi•Pearl River, NY

16h•Onsite

About The Position

Manager, GMP Facility and HSE Readiness is a pivotal operational leadership role responsible for maintaining our Pearl River manufacturing facility in a state of GMP compliance, equipment readiness, and workplace safety excellence. You will lead a team of two maintenance technicians while orchestrating facility operations across GMP cleaning, equipment asset care, and HSE leadership. Your meticulous attention to detail, proactive problem-solving, and hands-on approach will ensure our manufacturing environment meets the highest standards of regulatory compliance and operational integrity—directly enabling Sanofi to deliver life-saving medicines to patients worldwide.

Requirements

Bachelor's degree in engineering, Biology, Life Sciences, or related field required or 5+ years of equivalent experience in a GMP biopharmaceutical or pharmaceutical manufacturing environment.
5+ years of experience in GMP equipment maintenance, asset care, or reliability programs in a 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
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
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

Nice To Haves

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

Responsibilities

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
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
Review and Close Preventive and Corrective workorders as the pertain to the Manufacturing floor
Execute and complete Corrective and Preventive Actions (CAPAs) as applicable
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
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