Process Engineer II Job at Engineering & Maintenance at SanofiLocation Framingham, Massachusetts Job Category Engineering & Maintenance Requisition Number POS_00474921-0003JC
Sanofi Genzyme focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families.
Genzyme Corporation (a Sanofi company) 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.
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 RESPONSIBILITIES:
The Process Engineer II works in the Manufacturing Science and Technology group to provide expert technical support to Commercial Operations at the Framingham Biologics site. He / she will:
· Provide technical support to GMP operations in a multi‐product cell culture and purification plant. Area of focus for this position will be Media, Cell Expansion, Bioreactor, and Cell Banking.
· 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 minor proposed changes to cell culture or purification processes.
· Completes technical investigations and provides on the floor technical expertise.
· Generate documents (technical memos and reports, protocols, etc.,) related to process monitoring programs and non‐conformances.
· Participate in cross functional initiatives.
· Degree in chemical engineering/Biochemistry/Biotechnology/Biological sciences or other relevant discipline. BS in engineering with at leas 5 years OR MS in engineering with at least 3 years experience in a cGMP manufacturing environment.
Hands-on experience in running, developing and troubleshooting protein purification, UF/DF, TFF, and filtration processes.
Knowledge of large scale biotechnology unit operations, principles of SIP and CIP, principles of biochemical engineering, and process data analysis.
Understanding of compliance and cGMP considerations.
Demonstrated commitment to continuous improvement – at the individual, department and organizational levels.
Experience with high level data analysis and strong technical writing and presentation skills.
Experience in the scale up and operation of large scale biotechnology processes.
Hands-on experience with large scale biotechnology unit operations.
Process development experience is highly desirable.
Publications in high impact journals.
Prior experience in leadership roles with direct reports (if any).
Experience in working with cross functional teams in high paced environment.
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.
• Strives for results – sets ambitious tangible and measurable targets ; takes personal responsibility for achieving results; reviews and evaluates progress against agreed targets, timelines and budgets
• Cooperates transversally – Shares information and seeks input from outside direct team. Develops strong cross functional relationships and partnerships with science and commercial organization
• Commit to customers- Shares relevant information openly and seeks appropriate input from others outside of the direct team; develops and maintains effective cross-functional working relationships and partnerships; responds positively and constructively to requests for support from across the organization
• Act for Change – Creatively challenges the status quo to find new ways of working; looks for the opportunities that arise during times of change; readily adapts to new environment, jobs, technologies and processes
Job : Engineering & Maintenance
Primary Location : United States-Massachusetts-Framingham
Job Posting : Feb 17, 2017, 1:21:52 AM
Job Type : Regular
Employee Status : Regular