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Process Engineer I (Engineering)


Location: Framingham, Massachusetts
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Description:
Support ongoing manufacturing process and technical transfer projects for protein based biopharmaceutical as part of the Manufacturing Sciences team. Subject Matter Expert (SME) for development and validation, health authority inspections, and investigations. Responsible for defining and supporting continuing validation program, process improvements, support execution and documentation of development and/or validation studies and contribute to quality event investigations, Document and interpret study results with recommendations. Provide technical leadership as a subject matter expert in multiple areas of responsibility. participate in developing process control strategies. Provide technical assistance to manufacturing and quality operations for process troubleshooting, and health authority inspections to achieving site metrics (+QDCI). Expertise in downstream unit operation design typically used in biotech/vaccine manufacturing (harvest/clarification, UFDF, viral filtration and large scale Chromatography) . Knowledge of computer software common to mission (Excel, JMP, Spotfire ) is preferred. Strong experience in GMP environments. 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. Experience in equipment start-up, qualification and validation is preferred. Bachelor's Degree/Undergraduate Degree or Advanced Degree in chemical or biochemical engineering.

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