Job Title: Manager, GMP Facility and HSE Readiness
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.
