Associate Engineer I (Quality Equipment Technical Support)

Associate Engineer I (Quality Equipment Technical Support)

Amgen Singapore Manufacturing

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 (Quality Equipment Technical Support) in Amgen Singapore Manufacturing.

Live

What you will do

The Associate Engineer will report to Manager, Quality Equipment Technical Support. This role is part of a team which collaborates with Quality Control (QC) Laboratory and Quality Assurance (QA), maintenance team and external service providers to perform equipment maintenance and validation activities. This role acts as the system owner for assigned equipment or systems, performing troubleshooting, preventive maintenance oversight, and continuous improvement, while contributing to system lifecycle management and validation activities.

Main Responsibilities:

Daily Operations

• Key contributor for assigned equipment performance and operation to ensure safety, compliance and sustained operation.
• Support the Asset Life Cycle Management of all Quality Equipment to support QC and QA to ensure compliance with safety/quality compliance, and sustained operation. This includes accountability to ensure asset lifecycle data, preventive maintenance and spare parts records are maintained to support equipment reliability and operational efficiency.
• Provide daily operational support to ensure continuous equipment availability; coordinate maintenance activities, track issue resolution.
• Perform and coordinate troubleshooting, repair, and preventive maintenance for analytical instruments and controlled temperature chambers, including daily equipment monitoring and coordination with external vendors.
• Maintain accurate documentation of engineering activities in accordance with current Good Manufacturing Practices (cGMP) and other applicable regulations, maintaining data integrity and audit readiness for all assigned systems.

• Liaise and coordinate with maintenance service providers and users as needed to support the full asset lifecycle, such as data management, preventive maintenance, and spare parts tracking.
• Accountable for minor equipment performance deviations and the investigation of major deviations and safety incidents.
• Support the process to identify and execute effective corrective and preventive actions and improvements to eliminate or mitigate future recurrence.
• Effectively communicate and collaborate with cross function stakeholders to address operational challenges and concerns to ensure sustained operation and minimal interruptions to operations activities.
• Support internal and external audits by preparing documentation, participating in inspection readiness walkdowns, and supporting reviews.
• Provide support for equipment change controls, commissioning, qualification, system validation, and periodic review activities, contributing technical input in engineering project tasks to ensure compliance with safety, quality, and operational standards.

Continuous improvements, Innovation and operational sustainability

• Ability to identify opportunities for continuous improvement to improve efficiencies and differentiation through flexible use of advance technologies and best industry practices.
• Support benchmarking of equipment performance (e.g., reliability, productivity) and contribute input to improvement activities identified
• Periodically review and/or improve equipment safety, maintenance strategy, spare parts, and other continuous improvement opportunities to enhance reliability.

Win

What we expect of you

Qualifications

• Bachelor’s Degree and 2 years of directly related experience in a pharmaceutical manufacturing site OR
• Associate’s Degree and 4 years of directly related experience in a pharmaceutical manufacturing site OR
• High School Diploma / GED and 6 years of directly related experience in a pharmaceutical manufacturing site.
• Familiar with documentation in a highly regulated environment
• Ability to work independently and collaboratively
• Good understanding in customer's voice and quality requirements is a must
• Strong team player, able to effectively work within and across teams
• Good planning and tracking skills, ability to use proper tools in program management and capable of managing multiple programs with respect to priorities
• Highly organized, ability to effectively manage timelines/ deliverables/ resources
• Strong interpersonal skills and verbal/ written communication; ability to distill complex information into simple and clear messages
• Ability to prioritize and multitask to enhance productivity and manage workload in a fast-paced, rapidly changing environment
• Demonstrates critical, creative thinking and problem-solving skills, and the ability to produce clear and concise written and verbal communication skills
• Strong customer-oriented personalities
• Ability to tactfully negotiate and positively influence peers, knowledge and experience in QC Laboratory and QA Analytical systems and CTC are added advantages.

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.

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.