Execute corrective actions/preventive actions (CAPA) and change control projects for aseptic improvement projects resulting from regulatory inspections and internal aseptic assessments/audits. Qualified candidates must have sound technical knowledge and experience with pharmaceutical aseptic and sterile manufacturing process development, process improvement, current regulations and regulatory inspections trends, working knowledge of Trackwise/change control systems. Qualified candidate must have ability to own and manage complex change controls and CAPAs resulting from regulatory inspections and internal audits. Working knowledge of the following pharmaceutical systems is preferred: Bosch TL-style filling machines for liquid and lyophilized vials, Bausch & Stroebel cartridge filling machines, IMA vial filling machines (CIP/SIP and single use fluid pathways), steam sterilization autoclaves, sterilization validation, aseptic process simulation (media fills), environmental monitoring in aseptic/sterile manufacturing, process FMEA/risk assessments.
This role is within the McPherson Remediation department, supporting the Aseptic Improvement team. Position will report to Team Leader and work as individual project owner and alongside other Pharmaceutical process engineers and contract engineers on aseptic/sterile manufacturing improvement projects. Successful candidate must have ability to lead complex, technical projects from initial concept/design phase through hands-on ownership of the change control process, and robust implementation of process improvements within aseptic/sterile manufacturing environments.