The Engineering Technical Authority Principal Engineer (TA) is responsible for engineering aspects of planning, design, construction, operations, maintenance and technical support of Amgen infrastructure, world-wide. The TA reports to the Engineering Technical Director (ETD) for Process Systems, and is
responsible for technical direction, leadership, guidance and support for a specific array of systems within an area of responsibility, such as Upstream Processes, Downstream Processes, Fill/Finish, CIP/SIP, Clean Utilities, Utilities, HVAC, Packaging, Devices, etc. Through their team(s) of global and site technical subject matter experts, the TA leverages 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 for a Single Use Component and Assembly Design SME and Network Leader in support of Drug Substance and Drug Product Engineering and Manufacturing.
The single use engineering SME will be responsible for: Partnering with key functional single use category leads in Quality, Supply Chain, Materials Sciences, Process Development (PD) and Sourcing to establish best practices in single use assembly design and specification management. Establish and lead a network of technical SMEs across the Amgen manufacturing and PD network to develop, drive and evolve best practices within the single use space, and to address issues and solve problems on behalf of the network. Development and implementation of a scalable process leveraging best industry practices for modular specifications to ensure fit for use, quality and flexibility in single use assembly design.
Establish the engineering process to incorporate Quality by Design into specification process for single use components and assemblies. Partner with clients at manufacturing sites and within PD to establish requirements and design standards for new single use systems, and provide oversight to the design process to ensure adherence to standards and good engineering practices. Support the establishment of new specifications and designs in support of project implementation across the Amgen network. Act as the engineering SME in support of vendor selection and management including issue investigations, root cause identification and CAPA establishment. Support development of, or approve operation
procedures for the safe, efficient and effective operations of single use systems. Develop, evaluate, approve and document system changes. Assist the sites in system troubleshooting, and take action as necessary to prevent future occurrence throughout the network. As a network lead, provide mentoring of other members of their network. Develop, implement and utilize business tools to perform technical responsibilities; establish measure and evaluate metrics, taking actions based on results. 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. Lead a geographically diverse team of engineers as part of an engineering network. Other such duties as may be assigned.
This position is located in Thousand Oaks, CA (ATO), but may also be located in, West Greenwich, RI (ARI), Cambridge, MA (AMA), or Juncos, PR (AML) and requires the ability to travel up to 25% including overnight stays.
Doctorate degree & 2 years of Engineering or Operations experience
Master's degree & 6 years of Engineering or Operations experience
Bachelor's degree & 8 years of Engineering or Operations experience
Associate's degree & 10 years of Engineering or Operations experience
High school diploma / GED & 12 years of Engineering or Operations experience
Bachelor or Advanced Degree in Engineering, Materials Sciences or Life Sciences
Professional registration, such as a Professional Engineer license
Proven ability to manage and deliver results in a highly fluid, interactive matrixed environment
10 years of engineering or technical experience in an engineering environment, with specific specialized expertise in the design, specification and management of Single Use Components for use in Biotech or related/applicable experience, or in the manufacturing of process components from plastics, polymers and elastomers
3 years managing or leading business processes for the scalable and modular specification of equipment preferably in the specification of single use assemblies from pre-qualified components
3 years of experience in executing engineering projects (cross functional team managing departmental or functional level projects) or Management of engineering initiatives to drive improved outcomes of Engineering projects
5 years of experience in engineering in biotech/pharmaceutical industry supporting manufacturing
Understands operational aspects of biopharma and/or engineering industries
Strong communication, relationship building, leadership and mentoring skills