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