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Process Engineer III Job at Engineering & Maintenance at Sanofi

Location Framingham, Massachusetts Job Category Engineering & Maintenance Requisition Number POS_00472038-0002JC
Process Engineer III-POS_00472038-0002JC

Process Engineer III- Manufacturing Science and Technologies (MSAT)-Downstream Purification

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 Summary
The Process Engineer III works in the Manufacturing Science and Technology group to provide expert technical support to Commercial Operations at the Framingham Biologics site.

Core Responsibilities
This individual will work within the Manufacturing Science and Technology organization with the following responsibilities:
  • Lend Expert technical support to GMP operations in a multi‐product cell culture and purification plant.
  • Be an invaluable partner to the Manufacturing and Quality organizations in daily operations to maintain the process in a reliable state of control.
  • Maintain process knowledge and ownership.
  • Perform expert 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.
  • Generate documents (technical memos and reports, protocols, etc.,) related to process monitoring programs and non‐conformances.
  • Lead and participate in cross functional initiatives.

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 at least 5+ years, or MS in engineering with at least 3+ years or a PhD with 1 years relevant experience in a cGMP manufacturing environment.

  • Minimum of 5-10 years’ Experience in on the floor support for large scale biotechnology purification processes.
  • Process development experience is highly desirable.
  • In depth understanding of large scale biotechnology unit operations, principles of SIP and CIP, and principles of biochemical engineering, and process data analysis.
  • Full Understanding of compliance and cGMP considerations.
  • Demonstrated commitment to continuous improvement – at the individual, department and organizational levels. #LI-GZ

Job : Engineering & Maintenance
Primary Location : United States-Massachusetts-Framingham

Job Posting : Feb 17, 2017, 1:08:59 AM

Job Type : Regular
Employee Status : Regular