Engineer I ( Engineering Compliance)

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.

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:

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  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.

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  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

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  Lead deviation triage, discussions and investigations for F&E with the support of Functional Area Owners and other SME.

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  Serve as F&E SME for cross functional RCA investigations.

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  Own and manage on time closure of F&E DQMS records (NCs, CAPAs and Change Control).

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  Participate in and coordinate engineering team regulatory Inspection readiness GEMBA Walkdowns and pressure tests preparation for respective F&E SMEs.

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  Represent department for site Inspection Readiness meetings, and as auditee for ASM internal audits.

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  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.

• 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 and quality requirements is a must

• Strong team player, able to effectively work within and across teams

• Strong interpersonal skills and verbal/ written communication; ability to distil 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 is an added advantage

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.

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

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

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.