Operations Engineer

Description

• Maintain a state of perpetual safety and GMP compliance on the shop floor, ensuring audit-readiness at all times
• Execute production, pre-maintenance, and post-maintenance intervention activities to meet manufacturing targets and reduce equipment downtime
• Ensure that pre-manufacturing checks are performed safely, compliantly in order to meet manufacturing plan
• Review operational tasks in alignment with Manufacturing Standard Work (MSW) and Operation Standard Work (OSW) to optimize workflow efficiency
• Lead/participate in troubleshooting activities for processing issues and deviations, collaborating cross-functionally to drive immediate and preventive actions to meet manufacturing targets and reduce equipment downtime
• Lead/contribute to EHS and quality investigations, generate reports, and drive resolution of issues identified during operations, batch record review, cleaning instructions review and associated manufacturing documentation
• Drive Continuous Improvement (CI) initiatives using the Plan-Do-Check-Act (PDCA) methodology to enhance safety, quality, and productivity
• Lead/support the development of risk assessments and job safety assessments (JSAs); participate in HAZOP reviews as needed
• Author and review Standard Operating Procedures (SOPs); ensure SOPs remain current and compliant
• Assist in commissioning, qualification, and validation (CQV) activities to support new equipment and process readiness
• Participate as a member of the emergency response team (ERT) when necessary.
• Development and review of changeover cleaning documentation and maintaining cleaning validation status

Development of changeover cleaning schedule and communication with cross functional departments for timely release of equipment for production

• Support manufacturing campaigns and changeover cleaning on rotating shift basis, as required
• Provide technical guidance for management of alarm responses and ensure alarm response is timely, appropriate and assessed as per SOP. Ensure that interlock bypass is performed safely and compliantly as per SOP
• Conduct hands on training including Structured On the Job Training (SOJT), Instructor Led Training (ILT), Job Safety Analysis (JSA), SOPs
• Perform structured gemba on operational activities for continuous improvement opportunities and active participation in good save initiative

Accountable for:

• Safe operation of plant and equipment
• Safety, cGMP, GDP, and SOP compliance
• Ensuring delivery of production plan inclusive of manufacturing and changeover cleaning

Qualifications

Degree in Engineering, preferably in Chemical Engineering or Degree in Science

Experience

Preferably, 2-3 years’ experience in a relevant manufacturing environment. Fresh graduates considered.