Senior Engineer (NPI & GLAM) - Process Engineering

About the role

Amgen is hiring a Senior Engineer for its Singapore manufacturing site (Tuas) in the Process Engineering team of the Facilities & Engineering department. Reporting to the Senior Manager of Engineering, the role leads equipment readiness for New Product and Technologies Introduction (NPI), GLAM and Site Projects in ASM1 and ASM2, acting as technical project lead and system owner for the Biotechnology/API manufacturing facility.

Key responsibilities

• Lead equipment readiness for NPI, GLAM and Site Projects and act as system owner, overseeing a team of system owners and SMEs
• Manage, plan, design and implement changes, commissioning and qualification activities (protocol/report review, FAT, SAT, PSSR, automation checkouts, IQ/OQ/PQ)
• Assess equipment during new product introduction and change controls to ensure it remains in a validated state
• Support design and engineering projects: business case, project charter, user requirements, conceptual and detail design, and work with project managers to deliver on schedule, budget and quality
• Collaborate with research, manufacturing, process development, utilities, maintenance, reliability, facilities, QA and validation on complex system modifications
• Coach and mentor engineers, build team capability and drive continuous improvement using data analysis and benchmarking

Required profile

• Doctorate, Master's or Bachelor's degree in Engineering or a related discipline, with 2, 4 or 8 years of directly related experience respectively
• Able to work independently with minimal supervision
• Experience managing stakeholder expectations for process equipment in biopharmaceutical/API settings
• Good oral and written communication, presentation and facilitation skills
• Strong analytical skills and business acumen