Scope of Function: The Senior Process/Project Engineer will have experience in pharmaceutical and/or biotech facility, a background with equipment design and will be responsible for the process engineering function in support of GMP manufacturing operations.
Reports to: Associate VP, Manufacturing Operations
The incumbent will 1) develop requirement specifications with end users of the new equipment, 2) specify and onboard new process and testing equipment, 2) support technical aspects of cGMP operations and tech transfer, 3) work within the defined quality systems for addressing CAPAs and Change Control documents to ensure effectiveness and efficiency of the manufacturing operation in compliance with GMP guidelines, 3) work with facilities that all process and testing equipment are properly qualified and calibrated, 4) author standard operating procedures, change controls, and CapEx justifications, and 5) be a contributing member of the GMP commercial expansion team.
Process: This individual will require an in-depth understanding of single use bioprocessing up to 2000L bioreactor process train for mammalian cell culture. Equipment sets include CO2 incubators, shaker platforms, rocker bioreactors, stirred tank bioreactors, mixing systems, depth filtration systems, purification skids, cross flow filtration skids, dose pumps and automated fill finish systems. The incumbent will have experience scaling processes between platforms.
This individual shall have a strong understanding of GMP’s and experience providing engineering support in a regulated pharmaceutical / biotech facility. Significant experience is required in the design and development, tech transfer, and manufacture of biopharmaceuticals. A strong track record working closely with process development or MSAT scientists to establish efficient GMP clinical and commercial manufacturing processes. Excellent communication and project management skills to facilitate interactions with internal groups, external collaborators and partners.
Project: As a member of the GMP commercial expansion team, the Senior Process/Project Engineer will specify and document requirement specifications for process equipment sets/systems, and coordinate the planning and onboarding activities. The position will require establishing equipment turnover packages for skidded process equipment trains working with Facilities and vendors. Working with Facilities the process engineer will ensure validation, calibration and prevent maintenance are scheduled and executed for, the equipment and cleanrooms. The incumbent will author/execute Engineering Studies as precursors to validation activities.
- Develop User Requirement Specifications, Functional Requirement Specifications for new equipment or modification of current equipment. Perform Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT)
- Identify key vendors to procure equipment, on-board the equipment, validate equipment and work through the Change Management process
- Establish equipment turnover packages for process equipment trains
- Working with Facilities to ensure the Execution of Commissioning and Qualification activities
- Working with Facilities to ensure the Design and execution of Installation Qualification (IQ), Operational Qualification (OQ) for equipment onboarding/modification/optimization
- Working with Facility to ensure the inclusion of all new or modified equipment into the site Maintenance/Calibration program
- Provide process engineering technical expertise for equipment selection and tech transfer into manufacturing
- Participate in tech transfer of process in collaboration with PD and MSAT representatives, including fit-to-plant, process risk analysis, timely review of tech transfer documentation, investigation support, and routine presentations to cross-functional teams and management
- Implement scale-up strategies for drug substance and product unit operations with a focus on process optimization within the CQAs and CPPs of the client product
- Work to ensure the successful start-up of manufacturing production campaigns. Engage team cooperation to facilitate resolution of cross-functional issues and/or provide value-adding solutions
- Build and maintain detailed timelines for development and transfer activities related to early or late-stage candidate production processes. Lead project planning and utilize Project
- Management methodologies
- Ensure official process related documentation is generated, reviewed, and delivered
Education and Experience Required
- Engineering (BME/ME/ChE) along with 6 to 10 years of experience working in a GMP manufacturing pharmaceutical or biotech environment
- Experience with equipment onboarding/validation
- Facility buildout experience
- Experience in writing and executing validation protocols, requirement specifications and SOPs
- Clear understanding of related SOPs and cGMPs as necessary to accomplish tasks
- Understands basic machine functionality (e.g. PLC’s, servo motors, controls, pneumatic function, power requirements, and safety guards)
- Understands utility requirements when specifying equipment
- Communicates clearly with internal and external stakeholders, both verbal and written
- Coordinates the development of engineering and GMP documentation, procurement, engineering services, construction, C&Q, and tech transfer