Engineering Technical Authority – Associate Director

Career Category

Job Description

Engineering Technical Authority Associate Director

Amgen Singapore Manufacturing

Join Amgens Mission of Serving Patients

At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980 weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology Inflammation General Medicine and Rare Disease we reach millions of patients each year. As a member of the Amgen team youll help make a lasting impact on the lives of patients as we research manufacture and deliver innovative medicines to help people live longer fuller happier lives.

Our award-winning culture is collaborative innovative and science based. If you have a passion for challenges and the opportunities that lay within them youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Live

What you will do

Lets do this! Lets change the world! In this vital role you will provide technical leadership and support for the planning design construction commissioning operations and maintenance of Amgens manufacturing infrastructure across the global network with emphasis on Singapore and the Asia Pacific region.

The Engineering Technical Authority (ETA) is responsible for technical direction leadership guidance and support for a defined portfolio of process systems within an area of responsibility such as Upstream Drug Substance Processes Downstream Drug Substance Processes Fill/Finish CIP/SIP Utilities HVAC Packaging and Devices. Through a network of global and site subject matter experts the ETA demonstrates engineering expertise both within Amgen and across the industry to optimize lifecycle management of Amgens assets and ensure performance and reliability across multiple sites.

This position is part of the Drug Substance Process Systems Engineering team with an emphasis on capital project design and execution for Amgen Singapore and projects across India and the Asia Pacific region. Additional responsibilities include end-to-end engineering support for future projects and technical leadership across the global network.

This role will serve as an Engineering Technical Lead (ETL) for major capital projects providing technical leadership across design construction and commissioning while ensuring aligned implementation of engineering standards and technical solutions across Amgens growing network. This role leads through technical authority project leadership and influence across site and global teams including technical leadership of contingent workers and dotted-line leadership of FTE partners. This position does not include direct people management of Amgen FTE staff.

Responsibilities:

Specific responsibilities include but are not limited to:

• Planning: Translate business needs into engineering solutions. Lead analysis of alternatives and recommend technical solutions for major projects. Publish and maintain engineering standards and specifications.
• Design: Lead design and equipment selection to optimize quality reliability and cost across the lifecycle of assets. Ensure appropriate use of technology and adherence to standards and practices. Approve exceptions to Amgen standards and specifications as appropriate.
• Construction: Leverage the ETA network to provide engineering support during construction including responses to RFIs resolution of complex technical issues and conflicts and support of overall project objectives.
• Commissioning: Ensure commissioning and qualification standards are developed and consistently applied. Leverage the network to provide engineering support for commissioning and qualification activities.
• Operations: Support the development of or approve operational procedures for the safe efficient and effective operation of systems. Review performance data and recommend improvements to system operations. Support non-conformance and preventive action investigations related to equipment failures.
• Maintenance: Support system failure analysis and approve maintenance standards and techniques. Review reliability and failure data and implement actions to improve system effectiveness and reliability. Assist sites with system troubleshooting and take action as needed to prevent recurrence across the network.
• Technical Leadership: Provide technical leadership to project teams contingent workers and the broader technical network. Lead through influence across site regional and corporate stakeholders to solve problems and deploy solutions across sites. Provide direction to contingent workers and technical oversight to dotted-line FTE team members supporting project and network objectives. Identify and resolve issues and conflicts. Mentor other members of the technical network. Drive technical decisions within project scope and network standards that span the global manufacturing network. Stay current on state-of-the-art systems and emerging technologies to support adoption of new techniques within Amgen. Represent Amgen with outside firms technical societies and regulatory bodies.

What we expect of you

We are all different yet we all use our unique contributions to serve patients. The collaborative professional we seek is a self-starter with these qualifications.

Basic Qualifications:

• Doctorate degree in Engineering & 2 years of Engineering industry experience OR
• Masters degree in Engineering & 4 years of Engineering industry experience OR
• Bachelors degree in Engineering & 6 years of Engineering industry experience

Preferred Qualifications

• Bachelors or advanced degree in Chemical Engineering Mechanical Engineering or another engineering discipline with life science experience.
• At least 5 years of experience working with Architectural & Engineering and Construction Management firms during design and project execution.
• At least 5 years of experience working in or supporting a biologics drug substance manufacturing facility.
• Demonstrated technical leadership of cross-functional teams in design execution and the ability to drive timely decisions through executive levels.
• Strong understanding of drug substance process engineering and manufacturing unit operations.
• 15 years of combined engineering experience including capital project design with a proven track record of delivering complex projects in a regulated environment.
• Extensive experience providing technical support to manufacturing processes equipment and facilities.
• Financial acumen to deploy initiatives that add shareholder value.
• Excellent communication and interpersonal skills with the ability to build strong relationships with stakeholders at all levels of the organization and across Amgens international network.
• Proven ability to manage multiple projects simultaneously and deliver results in a fast-paced environment.
• Experience providing technical leadership to project teams contingent workers and matrixed or dotted-line resources in support of engineering and capital project objectives.
• Experience supporting capital projects and engineering programs across multiple sites or regions preferably in Asia Pacific.
• Experience working in a global matrix organization with cross-cultural and cross-time-zone stakeholder engagement.
• Knowledge of industry trends (e.g. regulatory compliance technology human performance programs sustainability and asset protection) to stay at the forefront of technology implementation.
• Knowledge of applicable regulations and standards (e.g. cGMP building codes Boiler and Pressure Vessel codes) to ensure compliant design and execution.
• Ability to represent Amgen with outside firms technical societies and regulatory bodies.

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 professionaland 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 and make a lasting impact with the Amgen team.

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