Sanofi Group Process Engineer Associate, Purification in Framingham, Massachusetts
Process Engineer Associate, Purification
Sanofi, a global healthcareleader, discovers, develops and distributes therapeutic solutions focused onpatients’ needs. Sanofi has core strengths in diabetes solutions, humanvaccines, innovative drugs, consumer healthcare, emerging markets, animalhealth 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 leadingglobal healthcare company dedicated to discovering, developing and distributingtherapeutic solutions focused on patients’ needs.
Sanofi has core strengths in diabetes solutions, human vaccines,innovative drugs, consumer healthcare, emerging markets, animal health andGenzyme.
Sanofi US employs approximately 17,000 people across the country alldedicated to protecting health, enhancing life and responding to the hopes andpotential healthcare needs of seven billion people around the world.
Commitment is our Strength. Ready to grow together?
Sanofi US endeavors to makeour career center accessible to any and all users. If you are experiencingdifficulty and need assistance applying online, please call 1-800-207-8049Option 7, then Option 3.
Sanofi US Services, Inc. and its U.S. affiliates are Equal Opportunity andAffirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment withoutregard 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 violencevictim status; atypical cellular or blood trait; genetic information (includingthe refusal to submit to genetic testing) or any other characteristic protectedby law.
Manufacturing Science and Technology (MSAT) is the keeper of the body of manufacturing process knowledge, supports the creation of the instruction set and ensures manufacturing operations stay aligned with the registered process. MSAT is responsible for:
Providing daily on-the-floor technical support.
Providing technical leadership in process-related investigations.
Overseeing and leading data management & monitoring/SPC review processes.
Developing strategy for process validation activities.
Maintaining the Process Control Strategy and Operating Control Strategy.
Identifying and implementing commercial process/product life cycle improvements.
Defining relevant operational/technical standards and practices for the site.
Identifying and driving implementation of improvements to maximize throughput and capacity utilization.
Utilizing and maintaining robust scale down models to support manufacturing operations.
The primary objective is to ensure manufacturing processes are capable, compliant, in control and continuously improved.
**POSITION OVERVIEW/KEY RESPONSIBILTIES\
The Associate Process Engineer works in the Manufacturing Science and Technology (MSAT) group to provide technical support to commercial operations at the Framingham Biologics site. Responsible for supporting deviations or manufacturing investigations, process troubleshooting, raw material evaluation, support of validation programs, exploration of process design space and continuous process improvement.
This individual will work within the MSAT organization with the following responsibilities:
Provide technical support to GMP operations in a commercial CHO cell culture and purification manufacturing facility.
Partner with Manufacturing and Quality organizations in daily operations to maintain the process in a reliable state of control.
Develop process knowledge
Perform process monitoring using variety of data analysis methods and techniques (e.g., excel, JMP, etc.)
Function as a technical resource for the resolution of deviations, investigations and process issues.
Generate documents (technical memos and reports, protocols, etc.,) related to process monitoring programs and non-conformances.
Routinely troubleshoot operational issues with commercial process operations.
Assist with the proposal, initiation, testing and implementation of proposed changes to purification processes, utility and/or facility systems
Assist more senior engineers in the evaluation and implementation of process improvements, policy changes, compliance improvements and optimization programs.
Completes technical investigations and provides on the floor technical expertise.
* Key Responsibilities may differ among employees with the same job title and may change over time, in accordance with business needs.
LEADERSHIP QUALIFICATIONS: This position has direct reports.
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 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.
- BS in engineering with 0 – 1 years relevant experience in a cGMP manufacturing environment.
Experience with biotechnology processes.
Process development experience is highly desirable.
Job: Engineering & Maintenance
Primary Location: United States-Massachusetts-Framingham
Job Posting: Sep 22, 2016, 8:27:40 PM
Job Type: Regular
Employee Status: Regular