Process Expert

Job Description Summary The Process Expert for Upstream will be responsible for supporting manufacturing with technical knowledge within a defined discipline of Upstream operations including mammalian cell culture, harvest, seed train operation. Job Description Key responsibilities: Attend to production emergencies and act as first line of defense for operation-related troubleshooting and recommending corrections. Set up and ensure that routine manufacturing processes are effective and efficient. Attend to any quality incident and act as deviation investigation owner/CAPA owner as required. Author/reviewer for manufacturing related documents e.g. BRs, SOPs. Conduct operations and process monitoring, trending and optimization. Support cost reduction or yield/productivity improvement projects related to operations as needed. Support change control by owning or leading MU related actions. Actively support internal or external audit as Manufacturing representatives. Provide operations/user input/assessment and support equipment/area/system/facility modifications or acquisitions related to MU. Provide inputs in SAP MM setup. Essential Requirements: Minimum Bachelor degree in Chemical, Mechanical Engineering, Biotechnology or Life Sciences. Fluent in English. Minimum 3 years of experience in commercial manufacturing biotechnology processes i.e. cell culture is required. Must have an understanding of pharmaceutical industry trends and practices. Broad cGMP experience with knowledge and understanding of manufacturing, quality control, and qualification and validation required. Must have experience with production scale equipment such as stainless steel tanks, bioreactors, centrifuges, filtration systems, control systems (e.g. DCS or other SCADA, etc.) and CIP/SIP systems. Skills Desired: Change Control Chemical Engineering Continual Improvement Process Efficiency Flexibility Good Documentation Practice Knowledge Of CAPA Knowledge Of GMP Lean Manufacturing Manufacturing Process Manufacturing Production Physics Process Control Production Line Productivity Risk Management Root Cause Analysis (RCA) Scheduler Technology Transfer Well-Being #J-18808-Ljbffr