Process Engineer I – Biologics Process Equipment

About the role

Amgen is hiring a Process Engineer I for its Singapore manufacturing site (Tuas) in the Facilities & Engineering department. Reporting to the Senior Engineer, Team Lead or Manager, the role is the system owner for a portfolio of ASM1 process-support equipment, working with Engineering Support and Maintenance to keep plant operations running and to support the introduction of new products. The scope covers upstream and downstream areas such as cell culture, harvest filtration, viral inactivation, purification and bulk fill.

Key responsibilities

• Own day-to-day engineering support, equipment performance, validated state, maintenance plans and lifecycle actions for the assigned equipment.
• Lead equipment investigations, find root causes, recommend corrective and preventive actions and close them; present findings in regulatory inspections.
• Manage deviations and change controls for process equipment, acting as technical owner while final approval stays with Engineering and Quality.
• Support new product introduction, including equipment readiness, qualification support, punch-list closure and system turnover.
• Advise Manufacturing, Maintenance and Quality teams and support commissioning and qualification (FAT, SAT, IQ, OQ, PQ).
• Take part in system walk-downs, and share lessons learned with customers and managers.
• Use big data tools to analyse performance data for predictive monitoring and troubleshooting, and benchmark equipment reliability and productivity.

Required profile

• Master's degree in Engineering, or Bachelor's degree plus 2 years of directly related experience, or Associate's degree plus 4 years, or High School diploma / GED plus 6 years of directly related experience.
• Able to work independently under general direction and escalate novel or high-impact issues.
• Experience managing stakeholder expectations for process equipment in biopharmaceuticals is preferred.