Process Engineer III

Job description

Band Level 3 Job Description Summary: The Process Engineer III is responsible for providing engineering, validation and maintenance support to the process manufacturing equipment, facility and utilities at a site. The initial responsibilities for this role will be to support the design, build, and qualification of the equipment for a new large molecule drug substance facility. Upon project completion, the role will transition to engineering support and asset lifecycle management of the manufacturing equipment. Responsibilities: Ensures new equipment is appropriately designed/qualified and existing processes run in a compliant manner through equipment life cycle. Help define and optimize equipment qualification strategy. Owns and manages changes to the process equipment to maintain equipment in a validated state. Potentially take on a global role in ensuring consistency across manufacturing sites. Investigates any equipment or process deviations and developing corrective actions to prevent re-occurrences. Able to provide industry wide expertise for complex equipment and process investigations. Participates in all FDA and internal audits of the manufacturing facilities and process eq...