Process Engineer

ANTER CONSULTING PTE. LTD.; Singapore; On-site; SGD 90,000 - 150,000; Full time

Job summary

ANTER CONSULTING PTE. LTD. seeks an experienced Process Engineer — Upstream for a vaccine manufacturing project in Singapore. You will support commissioning, qualification and validation activities tied to an expansion, ensuring GMP operations remain uninterrupted.

Responsibilities include equipment commissioning, material qualification, process support across seed train to harvest, and PPQ execution with CAPA ownership. Strong written and spoken English is required.

Qualifications

• Degree in chemical, bioprocess or biochemical engineering or related discipline.
• 3–5 years in GMP biologics or vaccine manufacturing with upstream operations.
• Commissioning and qualification experience (IQ/OQ) on process equipment.
• Hands-on process validation including PPQ protocol authoring and execution.
• Deviations, investigations and CAPA ownership with root-cause analysis.

Responsibilities

• Site commissioning of upstream equipment including bioreactors and transfer systems.
• SAT support, loop checks, walkdowns and punch List closure.
• IQ/OQ protocols, redlining and deviation resolution to closure.
• CIP/SIP cycle commissioning, clean utility tie-ins and troubleshooting.
• Material qualification for upstream materials and supplier change coordination.
• PPQ runs, data capture and summary reports for GMP release.
• Support day‑to‑day upstream operations across seed train, cell culture and harvest.
• Change controls for process, material and equipment changes with impact assessment.

Skills

GMP Biologics

Upstream unit operations

IQ/OQ execution

Process validation

CAPA & root cause analysis

Change control

On-floor operations

Technical writing

Education

Chemical/bioprocess engineering degree

Job description

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.

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