Working at the direction of the Manufacturing Engineering team lead, supports setting up a GMP compliant clinical manufacturing facility. Assists with manufacturing engineering, process scale-up and problem solving with regards to equipment and systems. Collaborates with and supports Facilities, Process Development, Quality, Supply Chain groups.
May include some or all of the following:
Provide Engineering support to GMP manufacturing.
Responsible for troubleshooting and preventative maintaining the GMP equipment.
Lead the equipment design changes, change controls, CAPAs.
Work with external partners and vendors for developing specifications for equipment, instruments, and materials of construction.
Support process validation efforts.
Develop material balance and active process engineering based on materials flow.
Develop P&IDs to the process specifications.
Perform process scale up with input from Process Development and the Manufacturing teams.
Effectively collaborate with other team members, including engineers, chemists, quality specialists, and technicians for GMP plant operations.
Ensures regulatory, GMP standards and internal quality compliance for all project work.
Maintain a safety-first approach to manufacturing and support the in-house EHS program.
Education / Experience:
Bachelors or Master’s in Chemical Engineering with ≥7 years of experience in GMP/clean room manufacturing environment.
Equipment Qualification and Validation IQ/OQ/PQ experience in GMP/clean room environment.
Skills / Pre-requisites:
Working knowledge of methods and procedures used in the manufacture and quality control of APIs required.
Working experience with API associated equipment and downstream purification equipment (Chromatography, TFF).
Working experience with CAD or similar P&ID developing tools.
Must be highly motivated with good organizational and analytical/technical problem solving skills
Must be a self-starter with capability of working under minimal supervision and work well in a team based environment
Have effective written and oral communication skills
Computer skills in Microsoft Office suite including Project and Visio