Process Development Engineer (MSAT)

About the role

Amgen is hiring a Process Development Engineer for its Next Generation Biologics Manufacturing Facility in Singapore, one of the most advanced biotech manufacturing sites in the world, using single-use processing, connected processing and real-time process analytical technologies. The engineer provides scientific and technical support within the Process Development group.

Key responsibilities

• Coordinate non-routine activities such as technology transfer, process qualification, process performance monitoring and troubleshooting of unit operations
• Support new product introductions and lifecycle changes by integrating process design requirements with site procedures and capabilities
• Support make-a-batch exercises to assess facility fit and identify gaps
• Support feasibility and control strategy development for new equipment and technology
• Contribute to investigations and, depending on role level, lead them within a defined scope, preparing technical and product-impact assessments
• Build and maintain tech transfer efficiency tools, including templated documents and lessons learned
• Build relationships with drug substance technology teams, NPI, QA, Supply Chain and manufacturing teams
• Use strong technical and verbal communication skills in deviation assessments and presentations

Required profile

• Master's degree, or Bachelor's degree with 2 years of directly related experience, or Associate's degree with 6 years, or high school diploma with 8 years of directly related experience
• 4+ years of work experience in commercial manufacturing in biotechnology or pharmaceuticals
• At least 2 years' experience in regulated environments (cGMP)
• Ability to learn quickly, escalate issues to management, and communicate orally and in writing

Required skills

• Cell culture and/or purification process knowledge, including single-use technologies
• Troubleshooting unit operations and documenting investigations supporting cGMP production
• Working knowledge of regulatory and cGMP requirements

Selectees must meet the medical requirements of the job scope, which the company covers.