Process Engineer

Process Engineer — Upstream (Vaccine Manufacturing Project) We have an opening to support our client, a leading global vaccine manufacturer, on a capacity expansion project at their Singapore manufacturing site. About the project New materials, equipment and process trains are being introduced alongside a facility that continues to produce commercially, so the work has to progress without disrupting ongoing GMP operations. This is a process engineering role attached to the upstream train. You will bring new upstream equipment through commissioning, qualify the materials the process depends on, support engineering and trial runs through to Process Performance Qualification, troubleshoot the process when batches do not behave as expected, and carry the change controls that keep all of it compliant. It suits someone who wants to be on the floor during runs rather than at a desk, and who is comfortable working where the process is not yet fully established. Commissioning of upstream equipment • Site commissioning of new upstream equipment including bioreactors, media and buffer preparation vessels, skids and transfer systems • SAT support, loop checks, system walkdowns, and punch list generation and closure • Executing IQ and OQ protocols, redlining, and resolving protocol deviations through to closure • CIP and SIP cycle commissioning and troubleshooting, and supporting clean utility tie-ins • Working alongside vendors, engineering, automation and QA from commissioning through to handover into operations Material qualification • Qualifying new and alternate raw materials, media components, single-use consumables and filters for use in the upstream process • Running comparability and equivalence studies against incumbent materials, and defining acceptance criteria • Assessing extractables and leachables, compatibility and supplier change notifications, and coordinating with suppliers on technical documentation • Managing material introduction through change control, from justification and risk assessment to implementation and closure Upstream process support • Providing day-to-day technical support to upstream operations across seed train, cell culture and harvest • Monitoring process performance and critical process parameters, trending batch data and flagging drift before it becomes a deviation • Supporting media and buffer preparation, bioreactor operation, and the interfaces into downstream • Reviewing and revising batch records, SOPs and process descriptions as the process is established Trial runs and PPQ • Planning and executing engineering runs and trial batches, defining objectives, sampling plans and acceptance criteria • Authoring and executing Process Performance Qualification protocols, and writing the summary reports that support GMP release • On-floor support through runs, capturing observations in real time and feeding them back into the process definition • Supporting continued process verification in routine production Troubleshooting and change control • Investigating process deviations and out-of-specification results, applying structured root cause analysis and driving CAPA to closure • Diagnosing process and equipment issues on the floor alongside operations, automation and engineering • Raising, assessing and closing change controls for process, material and equipment changes, including impact assessment on validated status • Supporting inspection readiness and providing technical justification to QA What we are looking for • Degree in chemical, bioprocess or biochemical engineering, biotechnology or a related discipline • 3 to 5 years in GMP biologics or vaccine manufacturing, with a strong grounding in upstream unit operations • Commissioning and qualification experience, specifically IQ and OQ protocol execution on process equipment • Hands-on experience of process validation, including PPQ protocol authoring and execution • Demonstrated deviation investigation and root cause analysis capability, with CAPA ownership • Working knowledge of change control and its impact on validated status • Comfortable on the shop floor during runs, and able to work where the process is still being established • Accurate technical writing and good spoken English