Hard Services System Owner Specialist

BioSpace; Framingham (MA); On-site; USD 100,000 - 125,000; Full time

Job summary

Sanofi is seeking a Hard Services System Owner Specialist in Framingham, MA to define maintenance strategies with the Facility Management partner, contribute to design standards, and ensure regulatory compliance across equipment. You will support reporting on regulatory status and drive improvements in technical solutions for site performance.

The role requires a BS in Engineering or related field with 3+ years in cGMP environments; wastewater experience and relevant licenses are preferred.

Qualifications

• BS in Engineering, Facilities Management, Mechanical Engineering, or related field; 3+ years of industry experience.
• Extensive experience establishing and maintaining safe work practices in cGMP environments.
• Wastewater Treatment Plant experience preferred.
• Massachusetts Wastewater Treatment Plant Operator License preferred, or willingness to obtain.
• HVAC license preferred.
• Refrigeration or EPA certificate preferred.

Responsibilities

• Define maintenance strategy with Facility Management partner to guarantee performance.
• Contribute to design strategy by developing technical standards.
• Ensure regulatory compliance of equipment and have any reservations from inspections lifted; report regulatory status.
• Anticipate regulatory and technical developments likely to influence site activities/performance.
• Analyze, advise, and recommend improvements to technical solutions implemented.
• Challenge service delivery performance.
• Participate in deviation and root cause investigations.
• Communicate issues and resolutions to management, peers, and maintenance team.
• Lead process improvement initiatives.
• Vendor management.
• Own and support closure of HSE and Deviation CAPA action plans.
• Responsible for emergency response in owned areas.
• Participate in GEMBA actions and monitor KPI targets in HSE, Quality, and Work Management.
• Assist Hard Services Contract Supervisor and Head of Facility in achieving KPI targets.

Skills

Communication skills

Collaboration

cGMP experience

Wastewater experience

Regulatory awareness

Education

Bachelor of Science in Engineering / related field

Job description

Job Title: Hard Services System Owner Specialist

Location: Framingham, MA

About The Job

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.

About Sanofi

Were an R&D-driven, AI-powered biopharma company committed to improving peoples 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.

Main Responsibilities

• Jointly define with our Facility Management partner the optimal maintenance strategy to guarantee performance.
• Contribute to the design strategy by participating in the development of technical standards.
• Ensure regulatory compliance of equipment submitted and have any reservations resulting from inspections lifted. Ensure reporting to consolidate the site's regulatory situation.
• Anticipate developments (regulatory, technical, etc.) likely to influence the site's activities/performance.
• Analyze, advise, and make recommendations to improve the efficiency and effectiveness of technical solutions implemented.
• Challenge service delivery performance.
• Participate in deviation and root cause investigations as required.
• Communicate issues & resolutions to management, peers & maintenance team.
• Process Improvement Initiatives.
• Vendor Management.
• Own and support closure of HSE and Deviation CAPA Action Plans.
• Responsible for Emergency Response in the areas and systems they own.
• Participate in GOGEMBA site walk and own assigned GEMBA Actions.
• Help Hard Services Contract Supervisor and Head of Facility in monitoring and meeting KPI metric targets and compliance requirements in HSE, Quality and Work Management.

About You

Basic Qualifications

• Bachelor of Science degree in Engineering, Facilities Management, Mechanical Engineering, or related field with 3+ years of industry experience
• Extensive experience establishing and maintaining safe work practices in current Good Manufacturing Practice (cGMP) environments
• Wastewater Treatment Plant experience is preferred.
• Massachusetts Wastewater Treatment Plant Operator License preferred, or willigness to obtain.
• HVAC license preferred
• Refrigeration or EPA certificate preferred

Core Competencies

• Demonstrated excellence in written and verbal communication across all organizational levels
• Proven ability to collaborate effectively in cross-functional team environments

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 its 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 andwellness 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 Affictive 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.

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.