Sanofi Group Manufacturing Associate, Framingham, MA in Framingham, Massachusetts
*Rotating 12-hour DAY shift rotating including holidays, weekends, and business needs*
*Support Services experience a plus*
The Cell Culture Operations Department performs small and large scale cell culture operations, media preparation, equipment preparation, clean in place (CIP) and steam in place (SIP), and Preventative Maintenance of process equipment as part of a 24/7 large-scale therapeutic protein manufacturing facility.
This position is responsible for performing a variety of complex tasks under general guidance and in accordance with the manufacturing instruction set and current GMPs.
Practices safe work habits and adheres to Genzyme’s safety procedures and guidelines.
Demonstrates knowledge and understanding of GMPs and how they apply to specific responsibilities.
Follows accurate verbal and written procedures in operating production equipment and performing processing steps; accurately completes appropriate production documentation.
Identifies, escalates and documents events that deviate from normal operation; participate as needed in investigations.
Maintains cleanliness and orderliness of operational area.
Performs all operations in assigned operational area.
Stocks production area with supplies.
Performs batch record review, procedure revisions, and work order generation.
Monitors operations to ensure compliance with process specifications.
Conducts training for less experienced personnel.
Interacts with other support functions such as Quality Assurance, Quality Control, Manufacturing Engineering, MTS, Validation, etc.
Utilizes manufacturing knowledge to improve process operations and affect positive change.
Demonstrates ability to troubleshoot basic mechanical operations.
Effectively utilizes Microsoft office applications.
Demonstrates ability to follow detailed instruction set in order to execute production activities.
Builds, cleans and sterilizes equipment to support Media/Buffer Preparation, Purification and Cell Culture equipment preparation.
Demonstrates knowledge of Autoclave.
Demonstrates knowledge of Clean out of Place (COP).
Demonstrates general knowledge of gas and liquid filtration.
Demonstrates understanding PM, CIP and SIP operations to prepare equipment for Media Preparation operations.
Demonstrates understanding of application of sanitization practices.
Demonstrates ability to measure raw materials and operate basic Benchtop instruments.
Assists in directing work activities and training of other staff.
Key Responsibilities may differ among employees with the same job title and may change over time, in accordance with business needs
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.
- HS/GED with 3-5 years' experience or BS with 1-3 years' experience in a cGMP environment.
Preferred Qualifications :
Familiar process automation and deviation management systems (i.e. DeltaV and Trackwise).
Experience in reviewing and creating controlled documents.
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.