Manufacturing Engineer (Pharma)
External
Novexx · Tuas View Loop, SingaporePrepare for this interview
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About the role
Job scope Prepare, review, and update cGMP documentation, including batch manufacturing records, Standard Operating Procedures (SOPs), and related documents. Initiate and manage change control records to support process and system improvements. Develop technical training materials and deliver training sessions to enhance production staff competency. Support the transfer of new products and manufacturing processes, including conducting field trials and validation activities. Author, review, revise, and approve technical and engineering documentation, such as User Requirement Specifications (URS), Functional Specifications (FS), Safety Data Sheets (SDS), and Piping & Instrumentation Diagrams (P&IDs). Lead the design, procurement, commissioning, qualification, and implementation of new manufacturing equipment. Collaborate effectively within cross-functional teams to ensure efficient, compliant, and successful production of recombinant protein products.
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