Manager, GMP Facility and HSE Readiness

Job Title: Manager, GMP Facility and HSE Readiness

• Location: Pearl River, NY

About the Job

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.

About Sanofi:

 We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

Main Responsibilities

GMP Facility & Cleaning Operations (primary focus):

• 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

• Review and Close Preventive and Corrective workorders as the pertain to the Manufacturing floor

•Execute and complete Corrective and Preventive Actions (CAPAs) as applicable

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

About You

Basic Qualifications

• 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

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

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

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

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

Why choose us?

•  Bring the miracles of science to life alongside a supportive, future-focused team. 

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. 

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. 

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

• Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.

• Power industry-leading performance by leveraging digital, data, and AI-driven innovation – at speed and scale

• Transform lives worldwide by delivering life-changing treatments anywhere, anytime.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.