Sanofi Group Process Engineer Senior in Framingham, Massachusetts
*Monday-Friday- 1st shift*
*Onsite position with flexibility to work remote when appropriate*
*Fast-paced manufacturing environment*
*Direct experience with hands-on equipment*
*Cell culture/bioreactor experience a plus*
The Engineering Group at the Framingham Biologics manufacturing sites is responsible to ensure that the manufacturing equipment/systems used in the manufacture and storage of Sanofi Genzyme products are safe and fit for purpose in accordance with Sanofi Genzyme Corporate standards and industry regulatory requirements. This encompasses work processes that originate with the identification of new or revised assets; the design, installation, verification and validation of the assets; the maintenance of the assets in their commissioned/qualified/validated states; and the retirement of the assets at the end of their life.
This position, with minimal guidance, leads the engineering support of manufacturing, maintenance and capital projects. This position develops, organizes, analyzes and presents interpretation of results for operational issues or concurrent engineering projects of moderate scope and complexity.
Execute concurrent projects of moderate scope and complexity, with minimal supervision.
Interpret and execute policies and procedures. Recommend modifications to operating policies.
Lead a small group of engineers and/or technicians on an ongoing or project basis.
Actively participate and provide input and feedback for the Sanofi Genzyme Safety Program to meet Health and Safety regulations and OSHA requirements in all duties.
Function as a technical expert on equipment or systems; lead troubleshooting of operations, develop preventative maintenance procedures, and maintain engineering documentation.
Routinely audit the operational performance and regulatory compliance of a large number of highly complex equipment components or systems.
Lead efforts with manufacturing, process development, facilities, quality assurance and other departments in developing requirements and recommendations for system modifications.
Execute tasks, under the minimal direction of project managers, to complete design, engineering, construction, commissioning, and qualification for projects within schedule and budget constraints.
Coordinate the work of consultants and engineering firms on development of standard design documents.
Develop project scopes, schedules and budgets.
Obtain and critique quotes for system/facility modifications and work with vendors to execute.
Lead initiatives and/or projects.
Demonstrate skills in the following areas:
Schedule development, Facilitation, Collaboration, Basic project management completion and follow-up.
Utilize quality systems to ensure compliance with regulatory requirements.
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 investigations, deviations and CAPA
Provide support for documentation changes
Develop and manage change controls
Comply with requirements from Sanofi Genzyme’s Safety Program including Health and Safety regulations and OSHA requirements.
Demonstrate an ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:
Adhering to all applicable laws and regulations of the places in which
we conduct business, as well as our own Company policies and procedures.
Being honest and treating people with respect and courtesy.
Constantly striving to make Sanofi Genzyme a great place to work, and a company respected for the quality of its people and products.
Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.
- Bachelor’s degree in Engineering with 8+ years of Industry experience including 5+ years of GMP or Master’s with 5+ years of Industry experience with 3 years of GMP
General understanding of Quality Systems.
General understanding and wide application of technical principle, theories, and concepts in the Biotech/Pharmaceutical field.
General knowledge of other related disciplines.
Demonstrated skills in the following areas:
Problem solving and applied engineering
Basic technical report writing
Working knowledge of pharmaceutical/biotech processExperience in Bio-Pharmaceuticals Direct experience with regulated environments (i.e. cGMP, OSHA, EPA).
Working knowledge of specialized equipment/processes.General knowledge of Commissioning and Qualification.Effectively interact with a variety of communication and working styles.Ability to independently determine when additional internal/external resources are required to solve problems.
Single-use technology experience
Special Working Conditions:
Ability to gown and gain entry to manufacturing areas.
Required to support manufacturing operations on an “on call” 24/7 basis.
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.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.