Senior Engineer - Engineering Technical Authority

Career Category

Job Description

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.

Senior Engineer (Engineering Technical Authority)

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, world-wide. 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, Downstream Drug Substance, API, Fill/Finish, CIP/SIP, Utilities, HVAC, Packaging, Devices, etc. Through their team(s) of global and site technical subject matter experts, the ETA leverage engineering expertise both in the company and industry to optimize the life cycle management of Amgen’s assets and is accountable for performance and reliability across multiple sites.

This position is in the Drug Substance Process Systems Engineering team with an emphasis on antibody drug conjugate and peptide manufacturing

This role will include responsibilities as a domain expert on containment, facility, and process equipment during design, construction & commissioning for Amgen’s Antibody Drug Conjugate and Peptide portfolio.

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. Lead Engineering in development and execution of corporate environmental sustainability goals & projects.

Design: Lead design and equipment selection to optimize quality and cost across the total lifecycle of assets. Ensure appropriate use of technology, and alignment to standards. 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, 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 development of, or approve operation procedures for the safe, efficient and effective operations of systems. Review performance data and make recommendations for improvement of system operations. Support NC/CAPA investigations related to equipment failures.

Maintenance: Support systems failure analysis, 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 network.

Management: Lead design teams and technical network. Makes 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. Ensure technical decisions for assigned systems are optimized with those managed by other ETAs. Remain current on state-of-the-art for systems for adoption of new techniques and technology within Amgen. Represent Amgen with outside firms, technical societies and regulatory bodies.

Preferred location for this role is Amgen Thousand Oaks. San Francisco, Boston, and North Carolina will also be considered as alternate locations.

What we expect of you

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

Basic Qualifications:

• Doctorate degree OR

<