Sanofi Group Process Engineer III in Framingham, Massachusetts
Process Engineer III
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and Genzyme.
At Sanofi US, we are committed to the growth of our people, connected in purpose by career, life and health.
Headquartered in Bridgewater, NJ, Sanofi US is part of a leading global healthcare company dedicated to discovering, developing and distributing therapeutic solutions focused on patients’ needs.
Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and Genzyme.
Sanofi US employs approximately 17,000 people across the country all dedicated to protecting health, enhancing life and responding to the hopes and potential healthcare needs of seven billion people around the world.
Commitment is our Strength. Ready to grow together?
Sanofi US endeavors to make our career center accessible to any and all users. If you are experiencing difficulty and need assistance applying online, please call 1-800-207-8049 Option 7, then Option 3.
Sanofi US Services, 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.
PROCESS ENGINEER III
The facilities Engineering Group at Framingham Biologics manufacturingsite is responsible to ensure that the manufacturing equipment/systems used in the manufacture and storageof Genzyme products are safe and fit for purpose in accordance with Genzyme Corporate standardsand industry regulatoryrequirements. This encompasses work processes that originate with the identification of a new or revised asset, the design, installation, verificationand validation of the asset, the maintenance of the asset in its commissioned/qualified/validated state and the retirement of the asset at the end of its life.
POSITION OVERVIEW / KEY RESPONSIBILTIES
This position,with minimal guidance, leads the engineering support of manufacturing, maintenance and capital projects. Develops, organizes, analyzes and presents interpretationof 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 feedbackfor the Genzyme Safety Program to meet Health and Safety regulations and OSHA requirements in all duties.
Function as a technicalexpert 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, qualityassurance 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 qualificationfor 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 critiquequotes for system/facility modifications andwork with the vendorto execute.
Lead initiatives and/or projects.
Demonstrate skills in the following areas:
Basic project management
Completion and follow-up
Utilize qualitysystems to ensure compliance with regulatory requirements.
Partner with peers, team members, direct and indirect management chain to ensure the following:
Training plan execution
Ensure InspectionReadiness of assigned areas
Participate in timely completion of investigations, deviations and CAPA
Provide support for documentation changes
Develop and manage change controls
Complywith requirements from Sanofi Genzyme’s Safety Program including Health and Safety regulations and OSHArequirements.
Demonstrate an ongoing commitment to conducting our global businessaccording to the highest legal and ethical standards, and to continually pursueexcellence 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 whichwe conduct business, as well as our own Company policies andprocedures.
Being honest and treating people with respect and courtesy.
Constantly striving to make Sanofi Genzyme a great place to work, anda 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 inperforming our jobs.
Bachelor’s degree in Engineering with 5-8 years Industry experience in a GMP environment, or a Master’s with 3-8 years of Industry experience in a GMP environment
Working knowledge of pharmaceutical/biotech processes.
Direct experience with regulated environments (i.e., cGMP, OSHA,EPA).
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:
o Problem solving and applied engineering
o Basic technical report writing
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/externalresources are required to solve problems.
S PECIAL WORKING CONDITIONS
Ability to gown and gain entry to manufacturing areas.
Required to support manufacturing operations on an “on call” 24/7basis.
Job: Engineering & Maintenance
Primary Location: United States-Massachusetts-Framingham
Job Posting: Feb 3, 2017, 4:35:56 PM
Job Type: Regular
Employee Status: Regular