Process Engineer, Swiftwater PA

Job description

Summary of purpose/major responsibilities

The Process Engineer executes process design engineering activities for site capital and operational improvement projects within the Technical Services Engineering team in Swiftwater. This position is requires the participation in development of concept, design and fabrication, commissioning and qualification of process systems in a GMP environment

Provide engineering support to process engineering activities with scope definition, design and specifications, commissioning, qualification, and project quality and energy conservation. The engineer will design, specify and commission systems and provide engineering and problem-solving support for pharmaceutical manufacturing processes and projects

Key dimensions: headcount (direct and indirect) budget, doses, Capex… - Key indicators on which the job holder will be evaluated (WHAT in 9box):

Duties include 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 engineer is responsible for developing appropriate solutions to satisfy the needs of internal customers in accordance with company guidelines and procedures, and within budget and schedule commitments by applying and utilizing the methods of engineering.

This role will lead or participate in the development of URS's, equipment, instrument and component specifications, engineering calculations for mass & energy balances, computational fluid dynamics, engineering design including PFD and P&ID development, FAT and SAT planning/execution, initial start-up, commissioning and qualification of process systems.

The engineer will work closely with automation engineers to deliver process control of critical process parameters and critical quality attributes. This engineer works closely with project managers, maintenance and operational staff, other technical design, validation and engineering professionals, in a collaborative environment to provide effective and timely solutions to project and operational requirements

Requirements

Education/experience

Minimum B.S., Biochemical, Mechanical or Chemical Engineering.

3-10 years of experience in applied process design engineering relating to biological production. Knowledge of GMP requirements and commissioning and qualification would be beneficial. Formal training in fermentation/bioreactors and/or typical separation & purification technology applications in biologicals manufacturing is an advantage.

Individual with experience must have knowledge of unit operations typically used in biotech and vaccine manufacturing such as bulk manufacturing, downstream operations, formulation, steaming (SIP) and cleaning (CIP). Entry level opportunity exists for a candidate with the appropriate formal training and fit with in the organization. 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.