Process Development Engineer

About the role

Amgen is hiring a Process Development Engineer for its Singapore manufacturing site in Tuas. The role centres on coordinating complex, non-routine activities such as tech transfer process qualification, process performance monitoring, floor support and troubleshooting of unit operations, and supporting investigations in a regulated biopharmaceutical environment.

Key responsibilities

• Coordinate multiple complex activities including tech transfer process qualification, process performance monitoring, floor support and troubleshooting of unit operations
• Support or lead complicated investigations and communicate concisely with teams and leadership
• Compile and analyse process data using tools such as Excel, JMP and SIMCA to inform decisions and take predictive action
• Write technical protocols, technical assessments and product impact assessments
• Verify data in technical reports, spreadsheets and regulatory filings
• Communicate technically through writing and presentations

Required profile

• 4+ years of relevant work experience in commercial manufacturing within biotechnology or pharmaceuticals
• At least 2 years' experience in regulated environments (cGMP)
• In-depth cell culture process knowledge, including single-use and harvest technologies
• Experience providing floor support, troubleshooting unit operations and documenting investigations for cGMP production
• Basic understanding of regulatory and cGMP requirements
• Ability to escalate issues to project lead and line management
• Medical requirements of the job scope must be met; the company bears the cost of any medical checks

Required skills

• Excel, JMP, SIMCA
• Application of engineering principles and advanced statistical analysis to solve processing issues and improve processes
• Technical writing and presentation skills
• Problem-solving with strong scientific and engineering reasoning