Senior Engineer – Process Engineering (Calibration Program Owner)

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- Process Engineering, Amgen Singapore Manufacturing .

Senior Engineer – Process Engineering (Calibration Program Owner)

Live

What you will do

This role will serve as a technical lead for the Biotechnology Manufacturing facility in ASM for the facilities and engineering team. It will provide advance technical support for the calibration, maintenance, and application of instruments and analytical equipment. The role will be a liaison between corporate engineering and site operations in ensuring a robust calibration control programs are in-place and in compliance to AMGEN and regulatory requirements.

Experience in the operation of instrumentation and analytical equipment used in a biopharmaceutical environment will be required to support day to day manufacturing activities as well as to lead improvement projects. Overall biopharmaceutical processes' knowledge will be required to perform sophisticated solving activities. Applies advanced and diverse engineering principles to the design and implementation of major system modifications, process and/or capital projects. Develops, coordinates, analyzes and presents interpretation of results for operational issues or engineering projects of significant scope and complexity.

Responsibilities

General:

• Develop and maintain site calibration strategy and procedures, ensuring site specifics are aligned to global calibration and maintenance program. Lead or support internal and external audits related to calibration and metrology activities.

• Serve as the key point of contact for all calibration, instruments and analytical equipment related activities, collaborating with multi-functional teams to support production, quality, and regulatory compliance.

• Build and approve calibration data sheet from all projects and ensure of all data sheet in compliance with the rules set in CMMS as part of a Calibration Program.

• System Owner for all standards meter for site, responsible conduct regular assessments of metrology systems, instruments, and equipment to ensure accuracy and precision in measurement, adhering to corporate calibration program.

• Participate in any Supplier Audit to incorporate as “Approved Calibration Supplier” as part of a Calibration Program.

• Equipment/Process Equipment knowledge to perform sophisticated solving of equipment failures or malfunctions and/or the development of technical assessments.

• Supervise, coordinate and review work of a small staff of engineers, associates and/or technicians on an ongoing basis as well as on a project basis.

• Experience in validation processes such as generation/execution of Installation/Operation/Performance qualification documentation

• Experience in investigation of non-conformance, development of corrective and preventive actions and generation and implementation of change control.

• Demonstrate project management skills, application of concepts and apply knowledge of engineering principles and practices outside of area of field expertise to broad variety of assignments in related fields.

Strategic / Managerial (add advantage)

• Establish the strategic plans for cost and resource optimization by regularly discussions with key clients and global network to find opportunities,

• Build the best team by developing staff through annual Individual Development Planning and acting as a role model.

• As a member of the GMP F&E extended leadership team, partner with maintenance managers to improve instrumentation support.

• Triage and resolve issues related to instrumentation process non-conformances.

Technical

• SME of calibration program to develop and implement a comprehensive calibration program ensuring compliance with regulatory requirements per corporate programs to ensure alignment to QMS Metric Control Plan targets.

• Knowledge of regulatory requirement for pharmaceutical instrumentation application and analytical equipment. (USP857, USP645, ISO17025 etc.)

All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities

Win

What we expect of you

Qualifications

• Doctorate Degree OR

• Master’s degree in engineering and 2 years of experience, preferably in related pharmaceutical company or GMP environment or oil/gas industry OR

• Bachelor’s degree and 4 years of experience, preferably in related pharmaceutical company or GMP environment or oil/gas industry OR

• Diploma and 8 years of experience, preferably in related pharmaceutical company or GMP environment or oil/gas industry

• Experience in leading various collaborators’ expectations.

• Good interpersonal and facilitation skills necessary to forge consensus among competing client interests while ensuring objectives are met.

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’ 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

Your selection for this role will, may 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.

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.

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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.