Job Description

Career Category Engineering



Senior Engineer I \xe2\x80\x93 Process Engineering (Biologics)

Amgen Singapore Manufacturing, Singapore

HOW MIGHT YOU DEFY IMAGINATION?

Amgen is one of the world\xe2\x80\x99s 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 \xe2\x80\x93 Process Engineering (Biologics) in Amgen Singapore Manufacturing.

Senior Engineer I \xe2\x80\x93 Process Engineering (Biologics)

Live

What you will do

The role will serve as a technical lead for the Biotechnology Manufacturing facility in ASM for the Process Engineering team in the Facilities & Engineering department. This role will assume the system owner role, taking ownership of various process equipment that are used for manufacturing process or supporting manufacturing process. It will be the subject matter expert (SME) to ensure that the equipment operates, function and performs reliability as intended and is maintained in a validated state.

The system owner must be able to effectively communicate and collaborate closely with the stakeholders 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.

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:

• 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 minimal 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 to ensure equipment are in its validated state.
• Provide technical expertise in site selection assessment to identify equipment/facility gaps, select new equipment, assess layout/utilities capacity and partner project managers to develop project cost and schedule.
• Lead F&E to participate in technical transfer activities and multi-functional meetings.

Continuous improvements, Innovation and operational sustainability:

• Participate in related AMGEN network forums to determine innovative opportunities to improve reliability, efficiency, agility and differentiation.
• Continuously improve business intelligence capabilities applying big data analysis tools to extract, analyze and trend performance data for predictive monitoring and solving.
• Actively seek opportunities for continuous improvement to improve efficiencies and differentiation through flexible use of new technologies and best industry practices.
• Review equipment performance (e.g., reliability, productivity) and benchmark against network or industry standards and determine improvement plans, with support from reliability engineer.

Design & Project Engineering:

• Work closely with project managers to introduce new equipment including development of business case, project charter, user requirement specifications, quality risk assessments, conceptual design, preliminary design, design specifications and detail design.
• Participate in design review and setup up of new asset and associated maintenance plan/spares in Maximo.
• Participate in commissioning and qualification experience activities such as protocol/report review and approval, FAT, SAT, PSSR, automation checkouts and IOQ.
• Work with research, manufacturing, process development, utilities, facilities, quality assurance and validation departments in developing requirements and recommendations for large and/or highly complex system/facility modifications.
• Work with project managers to complete design and engineering projects within schedule, budget and quality constraints.
• Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.

Organization Leadership

• Develop the best team by coaching and mentoring engineers to develop their technical competency and leadership skills.
• Work in teams by educating customers on lesson learns, collaborate with customers managers to identify knowledge or trainings gaps.
• Deliver strong result in the right way by consciously being a role model that ensure results are deliver without compromising on core AMGEN values.

Win

What we expect of you

Qualifications

• Doctorate degree in Engineering OR
• Master\xe2\x80\x99s degree in Engineering and 2 years of directly related experience in a pharmaceutical manufacturing site OR
• Bachelor\xe2\x80\x99s degree in Engineering and 4 years of directly related experience in a pharmaceutical manufacturing site OR
• Diploma and 8 years of directly related experience
• Able to work independently with minimal of no supervision.
• Experience in handling various stakeholders\xe2\x80\x99 expectations related to process equipment in biopharmaceutical.
• Good communications skills, both oral and written, including presentation skills.
• Good interpersonal and facilitation skills necessary to forge consensus among competing client interests while ensuring objectives are met.
• Strong analytical skills and knowledge of industry trends to identify potential improvement opportunities. Ability to combine technical problem-solving skills with business acumen to determine best business solution.
• Working knowledge of biopharmaceutical processes such as chromatography, buffer / media tanks, viral filtration, tangential flow filtration is preferred. Process knowledge on inoculation, bioreactors, harvest, single use technologies and critical utilities will also be considered.
• Experience in validation processes such as generation/execution of Installation/Operation/Performance qualification documentation.
• Knowledge in Automation systems and processes such as RD\xe2\x80\x99s, Delta-V, BMS, ladder logic and PLC.
• Demonstrated project management skills (schedule/cost development, facilitation, collaboration, basic project management, completion and follow-up) and application of concepts.
• Problem solving skills requiring the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach.
• Flexibility to work off-hours.
• Knowledge of Total Productive Maintenance, Reliability Centered Maintenance concepts is an added advantage.

Thrive

What you can expect of us

As we work to develop treatments that take care of others, so we work to care for our teammates\xe2\x80\x99 professional and personal growth and well-being.

• Vast opportunities to learn and move up and across our global organization
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Apply now

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

careers.amgen.com

Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

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Amgen