Operations Engineer - Upstream

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

Job summary

ANTER CONSULTING PTE. LTD. is seeking an Operations Engineer focused on upstream manufacturing for a vaccine facility expansion in Singapore.

You will help introduce new upstream equipment, materials and processes, working with manufacturing, engineering, automation and quality teams in a GMP environment. You will perform hands-on commissioning, qualification, process validation and technical support, with emphasis on IQ/OQ execution, PPQ protocols and deviation investigations.

Qualifications

• Bachelor's degree in Chemical/Bioprocess/Biochemical Engineering or related field.
• At least 3 years' GMP biologics or vaccine manufacturing experience with upstream focus.
• Hands-on commissioning and IQ/OQ execution for manufacturing equipment.
• Experience authoring/ executing PPQ protocols.
• Proven deviation investigations and CAPA with root cause analysis.
• Familiarity with change control and impact on validated equipment.

Responsibilities

• Support commissioning of upstream equipment including bioreactors and transfer systems.
• Execute IQ/OQ protocols and document deviations or amendments.
• Assist in validation activities and process performance qualifications.
• Provide technical support for seed train, cell culture, and bioreactor operations.
• Monitor process parameters, review batch trends and investigate issues.
• Coordinate with engineering, automation, quality and vendors for handover and project delivery.
• Update batch records and SOPs; participate in change controls and CAPA.
• Assist in commissioning/troubleshooting CIP/SIP systems and clean utilities interfaces.

Skills

Commissioning experience

Root cause analysis

CAPA investigations

Technical writing

Cross-functional coordination

Hands-on support on floor

Education

Bachelor's degree in Chemical/Bioprocess/Biochemical Engineering or related

Tools

DeltaV

MES (Manufacturing Execution Systems)

Electronic Batch Records

Minitab / JMP / PI

Job description

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.