Systems Engineer Utilities

Job Title: Systems Engineer Utilities

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. 

The MABC Maintenance & Engineering organization is responsible for providing Engineering support to organizations on the MABC.  This organization is comprised of 5 groups:  Engineering, Facilities, Facilities APU’s, Commissioning and Qualification and Projects and Controls. 

The MABC Maintenance & Engineering organization will be supporting the following groups at the MABC campus: (1) MABC Biologics - comprised of commercial Fabrazyme, Thyrogen and Global Cell Banking operations. (2) MABC Campus Facilities Operations - responsible for campus wide facilities and utilities operations per established Service Level Agreements and (3) MABC Campus - in the context of programs/projects requiring approval, planning and execution across the Sanofi groups on the MABC.  While each business has its own Engineering support group, the MABC Maintenance & Engineering organization will interact with all of these groups on projects/programs with campus impact.

This organization is responsible for providing Engineering support for all cGMP process and utility systems at Framingham Biologics, maintaining these systems in a validated state of control and ensuring uninterrupted business continuity.  This organization is also responsible for shared GMP systems on the Framingham campus as defined by Service Level Agreements.  The Capital Projects group is responsible for the planning and execution of projects and programs under its scope as determined by budget and other pre-established criteria, ensuring projects/programs are completed to established schedules and budget.  The Commissioning and Qualification groups will be responsible for providing C&Q support to systems and projects/programs within the scope of this organization.

This position, with general guidance, provides engineering support for manufacturing, maintenance and capital projects.  Develops, organizes, analyzes and presents interpretation of results for operational issues or engineering projects of small scope and complexity.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities

• 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 / participate with a small group of engineering and / or technicians on an ongoing project basis

• Activiely 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 the operational performance and regulatory compliance for a number utility related equipment and systems.  Provide recommendations for system 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 vendor to execute

Demonstrate skills in the following areas:

• Schedule Development

• Facilitation

• Collaboration

• Project management

• Completion and follow-up

• Utilize quality systems to ensure compliance with regulatory requirements – CCR, ECM, Engineering Life Cycle Documents

Partner with peers, team members, direct and indirect management chain to ensure the following:

• Training plan execution

• Ensure inspection readiness of assigned areas

• Participate in timely completion of investigation, deviations and CAPA

• Provide support for documentation changes

About You

Basic Qualifications

• 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 the following area

• 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

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.

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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