Sanofi Group Process Engineer III- Framingham , MA in Framingham, Massachusetts
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 provides technical and logistical support to Framingham biologics manufacturing facilities.
The primary objective is to ensure manufacturing processes are in control, capable, compliant and continuously improved. MSAT is responsible for:
• Developing strategy for process validation activities.
• Providing technical leadership in process-related investigations.
• Providing on the floor technical support and troubleshooting.
• Provide input to the Control Strategy.
• Identifying and implementing commercial process/product life cycle improvements.
• Defining relevant operational/technical standards and practices for the site.
POSITION OVERVIEW / KEY RESPONSIBILITIES*:
The Process Engineer III works in the Manufacturing Science group to drive the introduction of new products into the 8 New York Avenue Biologics facility. This includes, but is not limited to, planning and execution of validation programs, process troubleshooting, raw material evaluation, continuous process monitoring and improvement. It will be key to interface with the technical transfer sending units to assure a successful transfer of the new product. This person is also responsible for analyzing and drawing accurate conclusions and recommendations from the process and experimental data.
• Provide technical and logistical support to GMP operations in a multi-product cell culture and purification plant.
• Partner with Manufacturing and Quality organizations in daily operations to maintain the process in a reliable state of control.
• Develop process knowledge and ownership.
• Perform process monitoring using a variety of data analysis methods and techniques (e.g., excel, JMP, etc.).
• Provide technical support and analysis for the resolution of deviations, investigations and process issues.
• Identify, own and resolve process issues proactively.
• Lead the proposal, initiation, testing and implementation of proposed changes to the upstream process.
• Completes technical investigations and provides technical expertise.
• Generate documents (technical memos and reports, protocols, etc.,) related to tech transfer of new processes.
• Participate in cross functional initiatives.
* Key Responsibilities may differ among employees with the same job title and may change over time, in accordance with business needs.
A Bachelor’s of Science in Chemical Engineering / Biotechnology / Biological Sciences with 5 - 6 years’ experience in a cGMP manufacturing environment OR
A Masters in Chemical Engineering / Biotechnology / Biological Sciences with 2 - 4 years’ of relevant experience in a cGMP manufacturing environment OR
A PhD in in Chemical Engineering / Biotechnology / Biological Sciences with 0 - 2 years’ of relevant experience in a cGMP manufacturing environment.
Hands-on experience with large scale biotechnology unit operations, particularly cell culture processes; running, developing or troubleshooting
Knowledge in the principles of chemical engineering, and process data analysis along with strong technical writing skills
Process Validation Experience
Experience in working with cross functional teams in high paced environment
Demonstrated commitment to continuous improvement – at the individual, department and organizational levels
Strong presentation skills
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.
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
Sanofi, Empowering Life