Senior Engineer I

1 week ago

Singapore Amgen Full time

**Senior Engineer I - Process Engineering (Biologics)**

**Amgen Singapore Manufacturing, Singapore**

**HOW MIGHT YOU DEFY IMAGINATION?**

Amgen is one of the world’s leading independent biotechnology companies. For over 4 decades, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world. Japan and Asia Pacific (JAPAC) is the fastest growing region in Amgen. Now we are hiring a **Senior Engineer I - Process Engineering (Biologics) **in **Amgen Singapore Manufacturing**.

**Senior Engineer I - Process Engineering (Biologics)**

**Live**:
**What you will do**

Reporting to the Senior Manager of Engineering, this Senior Engineer position is primarily responsible for providing operation and New Product Introduction (NPI) support for multiple biologics products and process equipment. This role will serve as a technical lead for the Biotechnology Manufacturing facility in ASM for the Process Engineering team in the Facilities & Engineering department, which collaborates with Engineering Support and Maintenance team, to deliver uninterrupted plant operations. This function operates in conjunction with the manufacturing team to ensure the appropriate and accurate completion of cGMP maintenance activities with minimum disruption to manufacturing. The scope includes equipment preparation, buffer/media batching, cell culture, purification, drug substance bulk fill, and analytical operations etc.

This role will assume the system owner role and lead a team of system owners, taking ownership of various process equipment that are used for manufacturing process or supporting manufacturing process. It will be the domain expert (SME) to ensure that the equipment operates, function and performs as intended and is maintained in a validated state. The role includes the supervision and development of system owners and domain experts for process equipment and instrumentation, tasked with managing, planning and implementation of changes, driving deviation investigations, resolving equipment related process interruptions and development of equipment maintenance program.

This role requires highly multi-functional interactions with key site functions to ensure success in production and release performance. Individual must be able to effectively communicate and collaborate closely with the team members and various SME to ensure equipment are operational to sustain daily operations, resolve operation challenges and implement effective measures to address the challenges to ensure without compromising on safety and compliance. It offers a broad exposure to all key aspects of GMP manufacturing as well as tactical and strategic teamwork within the extended worldwide engineering network.

In addition, it will also provide advance technical support/leadership to ensure the readiness of the equipment/ facility for successful introduction of new products in ASM. The role will be a liaison between corporate engineering and site operations in the design and implementation of new equipment and/or equipment modifications.

Main Responsibilities:
**Daily Operations**:

- Oversee direct production interruption investigation and serve as critical issue point for resolving equipment process related issues
- Build system and capabilities to drive improvements to equipment reliability and maintenance optimization
- Present equipment qualification and equipment related investigations and quality management system records in all site regulatory inspections
- Coach, mentor and/or cross train staff within core technical areas. Drive forward employee engagement activities to differentiate site/company as a great place to work
- Support NPI and Site projects as Engineering Technical Lead or Domain experts for process equipment
- Subject matter expert for process equipment performance and operation to ensure safety, compliance and sustained operation
- Effectively communicate and collaborate with cross function team members to address operational challenges and concerns to ensure sustained operation and mínimal interruptions to operations activities.
- Lead and participate in equipment breakdown investigations to identify root causes. Effectively communicate to the customers on the subsequent plans, short term, and long-term mitigating actions.
- Collaborate closely with multi-functional SME to implement effective corrective, preventive action and improvements to eliminate or mitigate future recurrence.
- Ensure operation continuity through asset lifecycle management planning, assess and identify impact to safety, compliance, operational schedule and cost.
- Perform assessment for equipment during new product introduction, change controls and other qualifications activities t

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