Principal Engineer

Amgen Inc. Cambridge , MA 02138

Posted 3 weeks ago

Career Category

Engineering

Job Description

Amgen is searching for a Principal Engineer responsible for planning, design, construction, operations, maintenance and technical support of Amgen manufacturing infrastructure, worldwide. (Job # R-78704). This Engineer can work out of our Rhode Island or Cambridge, Massachusetts campuses.

The Principal Engineer will operate as the Engineering Technical Authority (ETA) with responsibly for technical direction and leadership of key capital project(s). The ETA collaborates with the Engineering Technical Director (ETD) in our Process System Engineering team.

The ETA provides leadership, mentorship and support for a specific array of process systems including, Upstream Processes, Downstream Processes, Fill/Finish, Clean in Place/Sterilize in Place (CIP/SIP). Additionally, they provide technical/design leadership to Amgen projects, and lead global networks of site technical domain authorities. They could also lead a geographically disbursed team of engineers as part of a network that will have dotted line responsibility across many sites.

Key responsibilities include:

  • Work with clients, develop and specify engineering project plans, standards, specifications, equipment selection and design. Develop metrics to support procurement strategies for equipment, inventory management, spares and preventative maintenance.

  • Act as lead engineer overseeing project design teams including Amgen SMEs and A&E design teams. Leads design execution and acts as primary point of contact for design oversight. Lead design of new systems that support projects and technology deployment. Ensure designs optimize the total life cycle of the asset from a cost & efficiency standpoint.

  • Provide engineering support during construction processes, including responses to RFIs, resolving complex issues. Coordinate technical support teams including internal and external engineers ensuring project objectives and technical issues are resolved.

  • Ensure commissioning and qualification standards are developed and used. Provide support & lead aspects of C&Q for systems in project delivery teams.

  • Develop and approve procedures for the safe, efficient and effective operations of systems, including NC/CAPA investigations related to equipment failures.

  • Ensure the delivery of system maintenance including spare parts, maintenance plans, etc. Assist the sites in system troubleshooting.

  • Lead a diverse technical project team with both direct and indirect leadership responsibilities. Make use of expertise at the site and corporate levels for delivering designs, solving problems and deploying solutions. Engage the Amgen technical network to ensure SME feedback on the design process. Manages and provides technical mentorship to outside design firms. Represent Amgen with outside firms, technical societies and regulatory bodies.

  • This Principal Engineer can expect travel up to 30%.

Basic Qualifications

Doctorate degree and 2 years of Engineering experience

OR

Master's degree and 6 years of Engineering experience

OR

Bachelor's degree and 8 years of Engineering experience

OR

Associate's degree and 10 years of Engineering experience

Or

High school diploma / GED and 12 years of Engineering experience

Preferred Qualifications

  • Master's degree in Engineering, Physical or Life Sciences

  • Professional registration, such as a Professional Engineer license

  • 10+ years in a site and/or corporate engineering environment, with expertise in operations and equipment design for Drug Substance Engineering

  • 5+ years direct project engineering (technical design delivery) in support of equipment design

  • 5+ years in engineering in biotech/pharmaceutical industry supporting manufacturing

  • Experience in executing engineering projects - approving resources, assigning tasks, presenting achievements, cost/benefit analysis

  • Validated ability to lead and deliver results in a highly fluid, interactive matrixed environment

  • Strong communication, relationship building, leadership and mentoring skills

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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Principal Engineer

Amgen Inc.