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About the Role

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.

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
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

Requirements

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.
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
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
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
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

Skills

GMP
HSE compliance
Facility readiness
Equipment asset care
GMP cleaning operations
Maintenance
Preventive maintenance (PM)
Calibration
Shutdown planning
Safe work practices
5S implementation
Work permitting
Safety compliance
Environmental monitoring
cGMP regulations
Lean Manufacturing
Six Sigma

Location

Pearl River, NY

Work Type

Full-time

Experience Level

Manager
2+ years of experience in a GMP biopharmaceutical or pharmaceutical manufacturing environment

Education Level

Bachelor's degree

Salary/Compensations

$78.000,00 - $112.666,66

Benefits

Company employee benefit programs
High-quality healthcare
Prevention and wellness programs
14 weeks’ gender-neutral parental leave

About the Company

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale.
In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.
We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth.
Our deep understanding of the immune system and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world.
Together, we chase the miracles of science to improve lives.
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.
Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

Equal Opportunity

Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive 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.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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.