Provide engineering support for manufacturing, maintenance and capital projects for Framingham Biologics campus
Develop, organize, analyze and present interpretation of results for operational issues or engineering projects of small scope and complexity
Develop and execute projects of small scope and complexity
Interpret and execute policies and procedures
Perform load calculations and analysis to determine properly sized equipment
Lead or participate with a small group of engineering and/or technicians on ongoing projects
Actively participate and provide input and feedback for the Sanofi Health and Safety programs and policies
Function as SME for equipment and utility system operations
Routinely audit operational performance and regulatory compliance for multiple utility-related equipment and systems and provide recommendations for improvements
Perform design reviews for engineering, construction, commissioning and qualification for projects within schedule and budget constraints
Coordinate the work of consultants and engineering firms on the development of standard design documents
Obtain and critique quotes for utility equipment/system modifications and work with vendors to execute
Use schedule development, facilitation, collaboration, project management, completion and follow-up skills
Utilize quality systems to ensure compliance with regulatory requirements – CCR, ECM, Engineering Life Cycle Documents
Partner with peers and management to ensure training plan execution, inspection readiness, timely completion of investigations, deviations and CAPA, and support documentation changes
Requirements
Bachelor's degree in engineering
2 or more years or relevant work experience in an industrial manufacturing environment
Direct experience with regulated environments (i.e cGMP, OSHA, EPA)
Experience utilizing Quality Systems (CCR, ECM)
General knowledge of Commissioning and Qualification
Solid understanding and wide application of technical principle, theories, and concepts in the Biotech / Pharmaceutical field
Demonstrated skills in problem solving and applied engineering
Technical report writing
Ability to effectively communicate – written and verbal – across multiple departments of the organization
Demonstrated expertise (SME) in one or more of the following utility systems: HVAC; Pure Water Systems – WFI, RO, DI, Clean Steam; Compressed Air; Plant Steam
2 or more years' experience in pharmaceutical / biotech environment
2 or more years' experience HVAC Engineering
Ability to gown and gain entry to manufacturing areas
Required to support a 24/7 manufacturing operation on an as needed basis
Required to support building shutdowns as necessary
Benefits
Thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact
Wide range of health and wellbeing benefits including high-quality healthcare
Prevention and wellness programs
At least 14 weeks’ gender-neutral parental leave
Employees may be eligible to participate in Company employee benefit programs
Endless opportunities to grow your talent and drive your career (promotion or lateral move, at home or internationally)
Additional benefits information available via provided LINK
ATS Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
load calculationsdesign reviewstechnical report writingHVAC engineeringutility systemscommissioningqualificationproblem solvingregulatory compliancequality systems