Job Description

Career Category Engineering

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 an Associate Engineer (Utility) in Amgen Singapore Manufacturing.
Live
What you will do
In this vital role, the Associate Engineer (Utility) reporting to the Engineering, Manager (Utility), is responsible for ensuring that the utilities equipment and systems are designed, operated, and maintained according to detailed design specifications, operational needs, and Good Manufacturing Practice (GMP) standards. This will also include ensuring the system meets the requirements of quality, safety, engineering, regulatory and industrial standards.
This position will collaborate with cross-functional teams to gather and document system requirements, perform system testing, troubleshoot issues, and provide cross functional support including project execution team. Another key role will be interfacing with Amgen's Corporate Engineering Subject Matter Experts (SME).
As the Subject Matter Expert (SME) for utility system operations and maintenance, the Associate Engineer offers vital technical expertise throughout construction, commissioning, qualification, and regular operation phases. The Associate Engineer will liaise with external vendors to confirm that services meet contractual and quality standards. The Associate Engineer shall ensure adherence to established engineering practices and standards while actively seeking ways to optimize asset life cycle costs. The Associate Engineer will tackle complex technical issues, help develop commissioning and qualification documents and maintain regulatory compliance for utility systems.
A core part of this job is supporting site sustainability goals by implementing energy efficiency improvements, water conservation measures, and other environmental best practices within the utilities scope. The engineer will independently solve technical challenges, escalate matters when needed, work collaboratively across departments, and promote knowledge sharing to drive ongoing improvement and sustainable results.
Main Responsibilities:

• Primary responsibilities include acting as the System Owner and Subject Matter Expert (SME) for Clean (Purified Water, WFI, Clean Steam, Caustic Dilution System, Process Gases, etc.) and/or Black (Chilled Water, Steam, Compressed Air, Cooling Tower, Waste, HVAC, Downflow booth, BSC, Hood, CTC etc.) Utilities Equipment and Systems.
• Provide technical expertise to ensure safe and compliant system operation, hands-on support for process or equipment issues, monitoring and analyzing system performance.
• Collaborate with cross functional teams to support production, quality, compliance, safety and regulatory activities and requirements.
• Communicate effectively across multi-functional teams across the company (remote or otherwise).
• Partnership with Maintenance & Utilities operation team to ensure alignment on maintenance, operation, and system improvement plans
• Lead/own deviation investigation and ensure Corrective and Preventive Action (CAPA) is in place to prevent recurrence of similar incidents.
• Develop and oversee equipment maintenance program and alignment with compliance to standard, regulatory and network practices.
• Provide support for the development, periodic revision, review, and approval of Standard Operating Procedures, Risk Assessment, Preventive maintenance program and Job Plans.
• Coordinate and review the work of other team members or third-party resources on an ongoing basis as well as on a project basis.
• Support the Continuous improvement of Utilities system operating, maintenance and reliability program.
• Establish metrics to monitor, measure and ensure optimal utility operational performance.
• Participate in and support internal and external regulatory audits
• Serve as a key point of contact with the external vendor to ensure that all the Utilities system maintenance are in compliance with cGMP quality and regulatory requirements.
• Conduct systems engineering audits to ensure compliance to all relevant site SOPs, global SOPs, GEP and GDP.
• Participate in project as system SME to provide input on technical, safety and compliance aspect as applicable to ensure project success.
• Participate in the system walkdown, ensure the closure of punch items and support the takeover of the systems from the Project team.
• Collaborate with Commissioning team to support the commissioning of all Utilities system.
• Support and coordinate qualification and validation activities as the owner of the system.
• Support Site Sustainability program - Analyze Energy consumption data, benchmark the overall usage/consumption, and evaluate opportunities to optimize its usage.
• Support the development of business case to drive the site goal on sustainability targets.
• Prepare utilities consumption data for submissions to authorities.

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
Basic Qualifications

• Bachelor's degree in Engineering and 2 years of directly related experience or
• Associate's degree in Engineering and 4 years of directly related experience or
• High School Diploma / GED and 6 years of directly related experience
• Ability to work proactively, independently and collaboratively
• Good interpersonal and communication skills with high computer literacy
• Strong teammate, able to effectively work within and across teams
• Preferred at least 2 years of engineering, operations maintenance Utilities system in the pharmaceutical/Biologicals manufacturing processes or equivalent experiences.
• Proven experience working in GMP environment
• Knowledge on CMMS, BMS, QEMS, DeltaV
• Familiarity with documentation in a highly regulated environment
• Familiarity with computer validation processes and software testing techniques
• Engineering documentation expertise (e.g., P&IDs, User requirement specifications, functional specifications, design specifications and protocols)
• Proficient understanding with relevant industry standards (e.g. ASTM E2500, 21 CFR Part 11, USP, ISO14644, etc.)
• Strong analytical skills for problem solving and also to identify potential improvement opportunities.
• Project Management Skills running contractors and vendors.
• Interpersonal and facilitation skills necessary to forge consensus among challenging client interests while ensuring objectives are met in compliance and safe manner.
• Ability to thoughtfully negotiate and positively influence peers.
• Ability to provide On-Call support coverage on weekends
• Flexibility to work off-hour

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 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.
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Skills Required