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Process Engineer II (Engineering)


Location: Swiftwater, Pennsylvania
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Description:
This position will support a Sanofi Pasteur project currently being executed to implement a manufacturing process for Low Bioburden Bulk Adjuvant. The manufacturing process consists of five (5) manufacturing steps: raw materials dispensing and blending, premixing, emulsification, sizing filtration, and filling into storage bags, and an optional one (1) manufacturing step for in-line sterile filtration into a mixing bag. The engineer will be required to:
Develop process design basis, including P&ID creation and reviews, interfacing with A/E firms for equipment bid packages and ensuring proper sizing and selection of equipment, and interfacing with Automation/I&C for FRS generation. Participate in engineering and construction reviews. Review technical design and qualification specifications associated with ASTM E2500. Provide review and input to C&Q strategy and participate in testing of equipment. Provide technical assistance for process troubleshooting.
Knowledgeable in the following equipment and processes: Autoclaves, Parts Washers, CIP, Chemical Distribution, SIP and Buffer/Media Preparation.
Advanced knowledge of biotech equipment commissioning & startup procedures.
Working knowledge with navigating Delta V and Rockwell system interfaces as well as PLC-based control systems with experience in valve arbitration, wetted path pressure and flow control, alarm and phase logic control is required.
Knowledgeable in the basic requirements of cycle development and performance qualifications that involve item ranking, load patterns, load development, and recipe programming.
Knowledge of computer software common to mission (AutoCAD, Bluebeam, process simulation/scheduling, CFD) is preferred. Ability to work in cross-functional teams, provide strong analytical skills for troubleshooting and root cause analysis, and communicate with internal and external team members.
Proven experience is required for all individuals with field execution in a manufacturing environment. Previous experience in Swiftwater supporting capital projects with system design, start up, construction and commissioning within a vaccine bulk manufacturing facility is highly preferred.
Degree in engineering required.

Process exp in Cleaning and sterilization area a must (5-7 years) in a GMP environment, from design to qualification process. PLC automation and control systems required. Rockwell software is used, so need exp in this also needed. Adjuvant manufacturing is a plus. Person will need to be onsite at certain time every day, so they need to be local. Might be some travel as well. 

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