Process Development Engineer (MSAT)

The Process Development Engineer will provide scientific and technical support within the Process Development group at Amgen's Next Generation Biologics Manufacturing Facility in Singapore. This is one of the most advanced biotech manufacturing facilities in the world: employing the latest technologies for single use processing, connected processing, and real-time process analytical technologies.

• Applies engineering knowledge to coordinate assigned non-routine activities, including technology transfer, process qualification, process performance monitoring and troubleshooting of unit operations.
• Supports new product introductions (NPI) and lifecycle changes by integrating process design requirements with manufacturing site procedures and capabilities
• Supports make-a-batch exercises to determine facility fit and identify gaps.
• Support process feasibility and control strategy development for new equipment/technology introduction
• Contributes to investigations and, based on role level and assignment, may lead investigations within a defined scope; prepares technical and product-impact assessments and communicates findings to teams and leadership.
• Builds, maintains and improve tech transfer efficiency tools, including development of templated documents, implementation of lessons learned and more.
• Builds and sustains relationships with partners - drug substance technology teams, NPI, QA, Supply Chain, and manufacturing teams to ensure alignment between program needs and site capabilities.
• Utilize strong technical and verbal communication skills in deviation assessment and presentations

The core responsibilities apply to Engineer I and Engineer II. The complexity of assignments, degree of independence and technical leadership increase based on role level and demonstrated

• Master's degree OR
• Bachelor's degree and 2 years of directly related experience OR
• Associate's degree and/or 6 years of directly related experience OR
• High school diploma / GED and 8 years of directly related experience
• 4+ years of relevant work experience in the commercial manufacturing environment within the biotechnology or pharmaceutical industries
• At least 2 years' experience with regulated environments (i.e. cGMP) required
• Good cell culture and/or purification process knowledge, including single-use technologies
• Experience in troubleshooting unit operations, and resolving and documenting investigations to support cGMP production
• Problem solving skills requiring the application of strong scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach
• Demonstrated working knowledge of applicable regulatory and cGMP requirements
• Ability to learn and act on dynamic information at a rapid pace and escalate relevant issues to management when required.
• Self-motivation, adaptability and a positive attitude.
• Excellent communication skills, both oral and written.

Your selection for this role will be subject to fulfilling the medical requirements of this job scope. If so, you will be informed of the medical check(s) that you may need to undergo. All medical related expenses incurred from this medical check shall be borne by the company.