Engineer - F&e (Engineering Compliance & Support)

Career Category

Engineering

**Job Description**:
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 - F&E (Engineering Compliance & Support) in Amgen Singapore Manufacturing.

Engineer - F&E (Engineering Compliance & Support)

Live

What you will do

Main Responsibilities:
Quality & Compliance
- Support and represent department for site Inspection Readiness meetings, and as auditee for ASM internal audits.
- Member of F&E Triage team for all regulatory inspections, handling all inspection requests, preparing responses, and advising Subject Matter Experts on response strategy.
- Support inspection readiness and pre-audit walkdown to ensure F&E is in a state of compliance.
- Manage and track F&E Quality Management Review metrics and maintain appropriate visual boards
- Lead deviation investigation for F&E with the support of Functional Area Owners and other SME.
- Support F&E deviation triages.
- Own and maintain F&E Training Assignment Plan.

Operational Excellence
- Maintain appropriate visual boards and measuring systems for daily management.
- Manage departmental Business Performance metrics and provide reporting and escalations to the F&E leadership.
- Support the implementation of business-critical projects and to deliver work efficiency.
- Support the implementation of Operational Excellence and Continuous Improvement efforts in F&E, measuring labor productivity and identifying opportunities to increase productivity and establishing appropriate metrics and measuring systems.
- Support Change Management efforts for major functional initiatives & F&E Lean Transformation certification.

Engineering Innovation
- Work closely with stakeholders within the department to formulate digitalization strategy and initiatives.
- Work closely with stakeholders to understand operation processes, identify process deficiency, and collaborate with them in all digitalization initiatives.
- Define digital initiatives, implement digital solutions, and deliver expected business outcome.
- Provide effective coordination within the project working group and collaborate well with external functions.
- Manage the day-to-day project activities and resources and chairs the project management team meetings.

Win

What we expect of you

**Qualifications**:

- Bachelor’s Degree Computer Science/Engineering or any relevant field and 2 years of directly related experience in a pharmaceutical manufacturing site.
- Associate degree and 4 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
- Knowledge and experience in operation excellence and project management
- Ability to tactfully negotiate and positively influence peers, knowledge and experience in digitalization 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

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.

Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual