Manager, Engineering (Quality Equipment Technical Support)

Manager, Engineering (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 a Manager, Engineering (Quality Equipment Technical Support) in Amgen Singapore Manufacturing.

Live

What you will do

The Manager will report to Senior Manager, Engineering Support. This role leads a team of engineers which will be responsible for coordinating equipment maintenance and validation activities used by the Quality Control (QC) Laboratory and Quality Assurance (QA). The position requires close collaboration and communication with external service providers, QC and QA business owners and the Information Systems team to ensure business continuity and manage the asset lifecycle. The role is critical to enable the site to drive alignment to the Amgen network in enabling synergy and optimization of asset lifecycle operating costs while maintaining or improving reliability. It offers a broad exposure to validation, maintenance and operational excellence.

Main Responsibilities:

Engineering Technical Leadership

• Responsible for leading and supervision of staff, maintenance of the team’s work allocation and  prioritization.
• Lead and participate in the investigation and troubleshooting of major deviations and safety incidents relating activities managed by team.
• Recommend effective corrective actions, preventive actions and improvements to optimize equipment performance & reliability.
• Member of department Engineering Innovation & Continuous Improvement governance.
• Support department inspection readiness activities as required.
• Responsible for providing oversight to ensure that processes are followed in accordance to current Good Manufacturing Practices (cGMP) and other applicable regulations.
• Ensure sufficient budget, timely expense and invoicing to manage all activities undertaken by the team including outsourced maintenance and resource support.

Quality Equipment Technical Support

• Site subject matter expert for Analytical System Validation.
• Responsible for Asset Life Cycle Management of all Quality Equipment to support QC and QA to ensure safety/quality compliance and sustained operation.
• Management of analytical equipment and controlled temperature chambers maintenance and validation activities as system owner.
• Ensure accurate asset data, preventive maintenance, spare parts creation/maintenance.
• Ensure external maintenance and calibration vendors are qualified as required.
• Support vendor management external supplier audits.
• Manage systems validation and periodic review.
• Provide and support assessments required for long range planning for obsolete/ aging asset management.
• Own/manage change controls, work with capital project team closely to implement equipment as required.

Win

What we expect of you

Qualifications

• Doctorate degree OR
• Master’s degree and 2 years of Engineering OR
• Bachelor’s degree and 4 years of Engineering experience OR
• Diploma and 8 years of Engineering OR
• Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources
• Proven experience and track record of compliance in a highly regulated environment
• Demonstrated ability to effectively lead and partner in a complex, matrix environment
• Experience in Pharmaceutical / Biotechnology industries preferred
• Able to communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms
• Strong leadership skills, decision making, problem solving abilities
• Able to adapt to changing business needs and operational requirements
• Strong knowledge and experience in analytical systems, controlled temperature chambers and computerized systems operations, validation, reliability, calibration and maintenance.
• Lean/Six Sigma or other continuous improvement methodology experience (e.g., DMAIC, Value Stream Mapping, Process Mapping, Mistake-proofing, FMEA, Root Cause Analysis, etc.) are desirable skills.
• Excellent communications skills, both oral and written, including executive presentation skills
• Interpersonal and facilitation skills necessary to forge consensus among competing client interests while ensuring objectives are met
• Ability to work independently and collaboratively
• Ability to tactfully negotiate and positively influence peers and executive leadership
• Strong analytical skills to identify potential improvement opportunities
• Ability to combine technical problem-solving skills with business acumen to determine best business solution

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.

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

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.