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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%.
Doctorate degree and 2 years of Engineering experience
Masters degree and 6 years of Engineering experience
Bachelors degree and 8 years of Engineering experience
Associates degree and 10 years of Engineering experience
High school diploma / GED and 12 years of Engineering experience
Masters 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 peoples lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds 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.
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