We are partnered with a great client who has recently invested over 250 million dollars into their facility. The Senior Process Engineer will lead and manage advanced engineering activities, including process design, scale-up, and detailed documentation control. This role involves close collaboration with cross-functional teams, such as R&D, Quality Assurance, and Production, to provide technical leadership and expertise aimed at driving process improvements, enhancing operational efficiency, and ensuring compliance with industry standards like cGMP and FDA regulations.
Key Responsibilities:
- Develop batch records tailored to client-specific formulation and filling operations. Oversee processing activities (ENG and GMP), including equipment preparation, bulk product formulation, sterile filtration, and filling support to facilitate process design and internal technology transfer.
- Act as a subject matter expert (SME) for GMP investigations (e.g., CAPA, departures, CCRs) with support from senior engineering staff, and prepare closure reports for assigned process engineering departures. Engage in direct client communication for routine discussions, providing verbal and written summaries of engineering work, with support from senior engineers as needed.
- Identify and specify process-specific equipment for client technology transfers, developing techniques and process parameters that maintain critical product attributes. Create operational instructions and detail process flows within the cleanroom facility.
- Innovate new manufacturing processes to meet client needs while strictly adhering to safety protocols. Promptly raise any process deviations to the shift supervisor, engineering manager, and/or quality assurance.
Qualifications:
- Bachelor’s degree in Biology, Chemical Engineering, or a related field.
- At least eight (8) years of experience in a cGMP/FDA regulated environment.
- Preferred experience in aseptic fill/finish processes.
