Operations Engineer - Upstream

Seeking an Operations Engineer specialising in upstream manufacturing to support a capacity expansion project at an established vaccine manufacturing facility in Singapore.

The successful candidate will support the introduction of new upstream equipment, materials and processes, working closely with manufacturing, engineering, automation and quality teams. This role involves hands-on commissioning, qualification, process validation and technical support within an operational GMP environment.

Key Responsibilities

Support commissioning of upstream equipment, including bioreactors, media and buffer preparation vessels, process skids and transfer systems.

Participate in site acceptance testing, loop checks, equipment walkdowns and punch list resolution.

Execute Installation Qualification and Operational Qualification protocols, document amendments and resolve qualification deviations.

Support commissioning and troubleshooting of Cleaning-in-Place and Sterilisation-in-Place systems, including interfaces with clean utilities.

Assess and qualify new or alternative raw materials, media components, single-use consumables and filters.

Support material comparability and compatibility assessments, review supplier technical documentation and evaluate relevant extractables and leachables information.

Provide technical support for seed train, cell culture, bioreactor operations and harvest activities.

Monitor critical process parameters, review batch trends and investigate potential process performance issues.

Plan and support engineering runs and trial batches, including sampling plans and acceptance criteria.

Author and execute Process Performance Qualification protocols and prepare associated summary reports.

Support continued process verification as processes transition into routine manufacturing.

Investigate deviations and out-of-specification results, perform root cause analysis and drive corrective and preventive actions.

Manage change controls for equipment, materials and processes, including assessments of their impact on validated status.

Update batch records, standard operating procedures and process documentation.

Collaborate with vendors and internal stakeholders to support equipment handover, inspection readiness and compliant project delivery.

Requirements

Bachelor’s degree in Chemical Engineering, Bioprocess Engineering, Biochemical Engineering, Biotechnology or a related discipline.

At least 3 years of relevant experience in GMP biologics or vaccine manufacturing, with strong knowledge of upstream processes.

Hands-on commissioning and qualification experience, including IQ/OQ execution for manufacturing process equipment.

Experience authoring and executing process validation or PPQ protocols.

Demonstrated experience in deviation investigations, root cause analysis and CAPA.

Working knowledge of change control and its impact on qualified equipment and validated processes.

Comfortable providing hands-on support on the manufacturing floor during commissioning and production runs.

Strong technical writing, communication and cross-functional coordination skills.

Preferred Experience

Raw material or single-use consumable qualification, comparability studies or supplier change assessments.

Vaccine manufacturing, particularly recombinant or viral platforms.

Expansion projects within an operating GMP facility.

Technology transfer or new product introduction.

Process data analysis using tools such as Minitab, JMP or PI.

Familiarity with DeltaV, Manufacturing Execution Systems or electronic batch records.

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