Engineer I ( Engineering Compliance)

Singapore Manufacturing - Tuas JOB ID: R-248778 LOCATION: Singapore Manufacturing - Tuas WORK LOCATION TYPE: On Site DATE POSTED: Jul. 01, 2026 CATEGORY: Engineering Engineer I (Engineering Compliance)

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 Engineer I (Engineering Compliance) in Amgen Singapore Manufacturing.

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What you will do

The Engineering Compliance Engineer I is responsible for Engineering Compliance and serve as interface with site Quality Assurance team providing Quality oversight to Engineering team, provides support of complex engineering investigations, change control, and unexpected result investigations. This role will report to Senior Manager, Engineering Compliance & Support.

Main Responsibilities:

• Provide Engineering Compliance oversight and serve as interface with site Quality Assurance team providing Quality oversight to Engineering team, ensuring appropriate application and execution of GMP compliance requirements.
• Serve as liaison with site Quality Assurance team to support complex facility and engineering GMP compliance investigations including facility services, maintenance, utilities, and processing engineering aspects, ensure key performance indicator met targeted metric. The activities include management review, validation, change control and CAPA and ensure that engineering systems are managed in compliance with cGMP expectations
• Lead deviation triage, discussions and investigations for F&E with the support of Functional Area Owners and other SME.
• Serve as F&E SME for cross functional RCA investigations.
• Own and manage on time closure of F&E DQMS records (NCs, CAPAs and Change Control).
• Participate in and coordinate engineering team regulatory Inspection readiness GEMBA Walkdowns and pressure tests preparation for respective F&E SMEs.
• Represent department for site Inspection Readiness meetings, and as auditee for ASM internal audits.
• Lead and support F&E Triage team for all regulatory inspections, handling all inspection requests, preparing responses, and advising Subject Matter Experts on response strategy.

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What we expect of you

Qualifications

• Master’s degree in Science, Chemical, Process or Mechanical Engineering OR
• Bachelor’s degree in Science or Engineering and 2 years of directly related experience OR
• Associate degree in Science or Engineering and/or 6 years of directly related experience OR
• High school diploma in Science or Engineering / GED and 8 years of directly related experience
• Preferred 5+ years of relevant work experience in the commercial manufacturing environment within the pharmaceutical / biologics industry
• Related work experience (Quality Assurance, Engineering, manufacturing or process development) in the pharmaceutical/biopharmaceutical industry with progressively increasing responsibility
• Experience in providing investigations to support cGMP production
• Good communication skills (technical writing and verbal communication/presentation)
• Interacts effectively with variety of communication and working styles
• Experience with regulatory audits and inspections
• Problem solving skills with the ability to apply logic and assess data to reach decisions and solutions related to compliance and product quality Experience managing contractors and vendors
• Ability to work independently and collaboratively
• Good understanding in customer's voice a