Engineer I – Process Engineering (Biologics)
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Job description
About the Position
Engineer I – Process Engineering (Biologics)
Singapore Manufacturing - Tuas
JOB ID: R-258351
LOCATION: Singapore Manufacturing - Tuas
WORK LOCATION TYPE: On Site
DATE POSTED: Oct. 16, 2026
CATEGORY: Engineering
Join Amgen's Mission to Serve Patients
At Amgen, our shared mission to serve patients living with serious illnesses drives everything we do. Every team member plays an important role in helping advance science and deliver medicines that make a meaningful difference for patients around the world.
Amgen fights the world's toughest diseases by harnessing the best of biology and technology. We draw on our scientific expertise to push beyond what is known today and help people live longer, fuller lives.
If you are energized by collaboration, continuous learning, and meaningful work, we invite you to join our team and help make an impact.
Responsibilities
Daily Operations
- Own the day-to-day engineering support, equipment performance, validated state, maintenance plans, and lifecycle actions for an assigned portfolio of ASM1 Process Equipment.
- Present equipment qualification and equipment-related investigations and quality management system records in all site regulatory inspections.
- Subject matter expert for process equipment performance and operation to ensure safety, compliance, and sustained operation.
- Effectively communicate and collaborate with cross-functional stakeholders to address operational challenges and concerns to ensure sustained operation and minimal interruptions to operations activities.
- Lead equipment investigations of moderate complexity, identify root causes, assess technical options, recommend corrective and preventive actions, and drive approved actions to closure.
- Collaborate closely with cross-functional SMEs 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 periodic review and maintain process equipment in a validated state.
- Perform assessment for equipment during new product introduction, change controls, and other qualifications activities to ensure equipment are in its validated state.
- Accountable for deviation/change control associated with process equipment performance. Act as technical owner for assigned deviations and change controls, ensuring accurate technical assessment, timely execution, and closure. Final approval remains with designated Engineering and Quality approvers.
- Own defined equipment-readiness deliverables for NPI and site projects, including qualification support, punch-list closure, maintenance, and spare-parts readiness, and system turnover.
- Provide technical guidance to Manufacturing, Maintenance, Quality, and project teams for assigned equipment and coordinate implementation of agreed technical solutions.
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 utilizing big data analysis tools to extract, analyze, and trend performance data for predictive monitoring and troubleshooting.
- Actively seek opportunities for continuous improvement to improve efficiencies and differentiation through flexible use of advanced technologies and best industry practices.
- Benchmark equipment performance (e.g., reliability, productivity) and determine improvement plans.
- Build system and capabilities to drive improvements to equipment reliability and maintenance optimization.
- Periodically review and/or improve equipment safety, maintenance strategy, spare parts, and other continuous improvement opportunities to enhance reliability.
Design & Project Engineering
- Support the functional lead in providing ASM1 Process Equipment readiness support for NPI, GLAM, and Site Projects for Process-Support Equipment.
- Where appropriate, provide engineering advice to commissioning and qualification activities including FAT, SAT, automation checkouts, IQ, OQ, PQ, and asset/preventive maintenance/spare parts creation for new process equipment.
- Participate in the system walk-down, ensure the closure of punch items, and support the takeover of the system from the project team.
- Develop technical solutions to technical problems of moderate complexity requiring analysis and engineering judgment.
Organization Leadership
- Work in teams by educating customers on lesson learns, collaborate with customers' managers to identify knowledge or training gaps.
- Deliver strong results in the right way by consciously being a role model that ensures results are delivered without compromising on core Amgen values.
Requirements
Basic Qualifications
- Master’s degree in Engineering
- OR Bachelor’s degree in Engineering and 2 years of directly related experience
- OR Associate’s degree and/or 4 years of directly related experience
- OR High school diploma / GED and 6 years of directly related experience
Preferred Qualifications
- Ability to work independently under general direction and independently manage familiar assignments, escalating novel or high-impact issues.
- Experience in managing various stakeholders' expectations related to process equipment in biopharmaceutical.
- Good communication 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 the best business solution.
- Problem-solving skills require the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach.
- Working knowledge of biopharmaceutical processes such as chromatography, buffer / media tanks, viral filtration, tangential flow filtration, inoculation, bioreactors, harvest, single-use technologies, and critical utilities is preferred.
- Experience in validation processes such as generation/execution of Installation/Operation/Performance qualification documentation is preferred.
- Knowledge in Automation systems and processes such as RD’s, Delta-V, BMS, ladder logic, and PLC is preferred.
- Demonstrated project management skills (schedule/cost development, facilitation, collaboration, basic project management, completion, and follow-up) and application of concepts will be an advantage.
- Flexibility to work off-hours.
- Knowledge of Total Productive Maintenance, Reliability Centered Maintenance concepts is an added advantage.
We Offer
- Competitive benefits
- Development opportunities
- Collaborative culture
- Professional and personal growth
About the Company
Amgen is an organization dedicated to improving the quality of life for people around the world. We foster an inclusive environment of diverse, ethical, committed, and highly accomplished people who respect each other and live the Amgen values as we continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity Employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided 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 accommodation.
Apply now and help transform the lives of patients while transforming your career.
careers.amgen.com
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