Engineering Technical Authority – Associate Director

Engineering Technical Authority – Associate Director

Amgen Singapore Manufacturing

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s 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, you’ll 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, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

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What you will do

Let’s do this! Let’s change the world! In this vital role, you will be responsible for planning, design, construction, operations, and maintenance technical support of Amgen manufacturing infrastructure, worldwide. The Engineering Technical Authority (ETA) is responsible for technical direction, leadership, guidance, and support for a specific array 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, Devices, etc. Through their team(s) of global and site technical subject matter experts, the ETA will demonstrate engineering expertise both in the company and industry to optimize the life cycle management of Amgen’s assets and be accountable for performance and reliability across multiple sites.

This position is in the Drug Substance Process Systems Engineering team with an emphasis on capital project design and execution for Amgen in Asia (ASM, AIN, etc). Additional responsibilities will include end-to-end engineering support for future projects and technical global network management.

This role will include responsibilities as an Engineering Technical Lead (ETL) delivering on design, construction & commissioning for several large projects and to ensure aligned implementation across Amgen’s growing drug substance network.

Responsibilities:

• Planning:Translate business needs into engineering technology solutions. Lead analysis of alternatives and recommendations for technical solutions in major projects. Publish and maintain engineering standards and specifications.

• Design: Lead design and equipment selection to optimize quality and cost across the total lifecycle of assets. Ensure appropriate use of technology and adherence to standards/practices. Approve appropriate exceptions to Amgen standards and specifications

• Construction:Use their ETA network to provide engineering support during the construction process, including responses to RFIs, resolving complex technical issues and conflicts, and supporting overall project objectives.

• Commissioning:Ensure commissioning and qualification standards are developed and used. Use their network to provide engineering support to commissioning and qualification.

• Operations:Support the development of, or approve operational procedures for the safe, efficient and effective operations of systems. Review performance data and make recommendations for improvement of system operations. Support non-conformance and preventive action investigations related to equipment failures.

• Maintenance:Support systems failure analysis, and approve maintenance standards and techniques. Support and review reliability and failure data, and implement actions to improve effectiveness, and reliability of systems. Assist the sites in system troubleshooting and take action as necessary to prevent future occurrence throughout the network.

• Management:Lead their design teams and technical network. Make use of expertise at the site and corporate levels for solving problems and deploying solutions across all sites. Identify and resolve issues and conflicts. Provide mentoring of other members in their network. Drive technical decisions within a project scope and networks standards that span the global networks. Remain current on state-of-the-art systems for the adoption of new techniques and technology 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:

• High school diploma / GED and 14 years of Engineering or related technical field experience OR

• Associate’s degree and 12 years of Engineering or related technical field experience OR

• Bachelor’s degree and 7 years of Engineering or related technical field experience OR

• Master’s degree and 5 years of Engineering or related technical field experience OR

• Doctorate degree and 3 years of Engineering or related technical field experience

Preferred Qualifications:

• Bachelor’s or advanced degree in Chemical Engineering, Mechanical Engineering, or other engineering field with life science experience.

• At least 5 years working in Architectural & Engineering and Construction Management Companies during design and project execution.

• At least 5 years working in or supporting a biologics drug substance manufacturing facility

• Leadership of multi-functional teams to implement design and driving rapid decisions up to 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 consistent track record of delivering complex projects in a regulated environment.

• Extensive experience providing technical support to manufacturing processes, equipment, and facilities.

• Financial competence to deploy initiatives that add shareholder value.

• Excellent communication and interpersonal skills, with the ability to build strong relationships with team members at all levels of the organization and across Amgen’s international network.

• Ability to manage numerous projects simultaneously and deliver results in a fast-paced environment.

• Knowledge of industry trends (e.g., regulatory and compliance, technology, human performance programs, sustainability, asset insurance, etc.) to stay at the forefront of technology implementation.

• Knowledge of applicable regulations (e.g. cGMP, building codes, Boiler and Pressure Vessel codes, etc.), to ensure compliance. 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’ 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 and make a lasting impact with the Amgen team.

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