Deputy Director, Process Engineer, Technical Engineering, US - Vaccine

Position Overview

Summary of purpose/major responsibilities:

The Process Engineer leads and executes design engineering activities for site capital and operational improvement projects within the Technical Engineering team. In support of capital projects, the Process Engineer leads and participates in the development of concepts and specifications, design and fabrication, commissioning and qualification of process equipment systems in a cGMP environment. The Process Engineer will also support licensed cGMP operations by providing technical leadership for investigations/assessments, and by developing and implementing improvement projects.

This Process Engineer will lead and participate in the development of URS’s, equipment/instrument/component specifications, engineering calculations, computational fluid dynamics simulations, engineering design including PFD and P&ID development, FAT and SAT planning/execution, initial start-up, commissioning and qualification of process systems.

The preferred candidate will have expertise in one of two areas:

1. Mechanical motion, specifically systems used in aseptic filling and/or upstream manufacturing on egg-based vaccines

2. Bioreactors and other upstream processing equipment. Experience with recombinant protein vaccines produced in insect cells is a plus.

The incumbent is responsible for leading the effort to develop appropriate solutions that satisfy the needs of internal customers in accordance with company guidelines and procedures, and within budget and schedule commitments.

Responsibilities:

• Lead and develop technically sound process equipment concepts and scope for capital projects

• Specify and design equipment

• Manage equipment vendors to meet requirements as well as project cost and schedule

• Develop and execute C&Q deliverables

• Identify changes to improve processes and address root causes identified in investigations in a cGMP environment.

• Develop and implement improvements through cross-functional interactions.

• Interface with Operations to ensure the manufacturing process equipment operates in its validated state and consistently meets the production schedule. Continuous improvement is required.

• Provide Subject Matter Expert (SME) knowledge as required on equipment within area of responsibility.

• Closely interact with Operations / Maintenance to develop, implement and improve practices and procedures.

• Involve site Maintenance, Operations, Engineering and Continuous Improvement teams throughout the design process. At the conclusion of each project, provide efficient and detailed knowledge transfer to allow for appropriate support of process equipment.

Requirements:

• Minimum B.S., Engineering (Chemical or Mechanical preferred).

• 10+ years of experience in engineering. Knowledge of GMP requirements and commissioning and qualification is required. Formal training in machine design applied technology applications in biologicals manufacturing is an advantage.

• Ability to effectively communicate, interact and collaborate with internal and external team members is essential. This position requires strong analytical skills (ability to apply engineering principles to design), hands-on troubleshooting skills and the capability to utilize AutoCAD, analysis software and company quality system software.

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.

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