Sanofi Group Manufacturing Associate in Framingham, Massachusetts
*Rotating 12-hour DAY shift rotating including holidays and weekends. Overtime as per business needs*
*Purification experience a plus*
Sanofi Genzyme, the specialty care business unit of Sanofi, focuses on rare diseases, multiple sclerosis, oncology, and immunology. We help people with debilitating and complex conditions that are often difficult to diagnose and treat. Our approach is shaped by our experience developing highly specialized treatments and forging close relationships with physician and patient communities. We are dedicated to discovering and advancing new therapies, providing hope to patients and their families around the world. Learn more at www.sanofigenzyme.com .
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi is organized into five global business units: Diabetes and Cardiovascular, General Medicines and Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Consumer Healthcare.
Department Description :
The Solution Preparation Department performs media preparation, buffer 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.
Key Responsibilities :
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.
Develops and practices understanding of GMPs and how they apply to specific responsibilities.
Follows 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.
Stocks production area with supplies.
May perform support function for more senior operators.
Builds, cleans and sterilizes equipment to support Media/Buffer Preparation, Purification and Cell Culture equipment preparation.
Develops and demonstrates general knowledge of Autoclave.
Develops and demonstrates general knowledge of Clean out of Place (COP).
Media / Buffer Preparation
Develops and demonstrates general understanding of gas and liquid filtration.
Develops and utilizes understanding PM, CIP, and SIP operations to prepare equipment for Media Preparation operations.
Develops and demonstrates basic understanding of application of sanitization practices.* Key Responsibilities may differ among employees with the same job title and may change over time, in accordance with business needs
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.
Special Working Conditions :
Ability to lift up to 40 lbs.
Ability to stand for 6 hours in a production suite.
Ability to gown and gain entry to manufacturing areas.
Ability to work a 12 hour rotating shift and every other weekend, including holidays as scheduled.
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.