Process Mechanical Engineer, Technical Engineering, US

Job description

The Process Mechanical Engineer is responsible for the technical design and execution of both capital and improvement projects with a primary focus in the aseptic fill/finish area. In support of projects, the engineer will participate in the development of concepts and specifications, design and fabrication, commissioning and qualification of equipment in a GMP environment. The engineer will also support licensed GMP operations by providing technical leadership for investigations/assessments, and by developing and implementing improvement projects.

Typical deliverables the engineer develops include URS's, equipment, instrument, and component specifications, engineering calculations, computational fluid dynamics simulations, engineering design including PFDs and P&IDs, FAT and SAT planning/execution, initial start-up, commissioning and qualification of process systems.

The engineer will also be a hands-on, process and equipment oriented, technical leader for the aseptic filling area. This includes providing engineering support for the operation, control, and maintenance of all aseptic fill/finish equipment including: vial washers, depyrogenation tunnels, aseptic fillers, lyophilizers, capping equipment, trayloaders, denester/renesters, visual inspection equipment, autoclaves, RABS and Isolators.

This position will be a participant with the Manufacturing Technology team in the development and / or technology transfer of new solutions and modifications to our existing manufacturing process systems while adhering to established regulatory compliance requirements. The incumbent is responsible for developing appropriate technical solutions to satisfy the needs of internal customers in accordance with company guidelines and procedures, and within budget and schedule commitments.

Responsibilities:

- Participate in the development of technically sound concepts and scope for aseptic fill/finish 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 Industrial 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 Industrial Operations to develop, implement, and improve operations and maintenance practices and procedures.

Responsible for providing engineering to assigned project(s) and as required, assisting on production floor troubleshooting assignments. Responsible for determining how user requirements and quality requirements will be satisfied within the design solution that utilizes the laws of engineering, mathematics and physics coupled with a process mechanical engineering aptitude. Limited budgetary responsibilities.

Basic Requirements:

Minimum B.S., Mechanical or Chemical Engineering.

2+ years' experience in working knowledge of 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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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.