Sr Engineer - Form/Fill/Label/Pack Inspection
The Senior Engineer is responsible for planning, design, construction, and operations and maintenance technical support of Amgen manufacturing infrastructure, world-wide. The Engineering Technical Authority (TA) is responsible for technical direction, leadership, guidance and support for a specific array of process systems within an area of responsibility, such as Upstream Processes, Downstream Processes, Fill/Finish, CIP/SIP, Utilities, HVAC, Packaging, Devices, etc. Through their team(s) of global and site technical subject matter experts, the TA will 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 Process System Engineering team, the position is for an Engineering SME in the areas of Fill Finish and/or Packaging and Inspection Systems with responsibility for technical network and project engineering leadership.
Planning: Working with clients, as appropriate (e.g. PD, Quality, Manufacturing), develop and specify engineering standards, specifications, equipment selection and design. Develop metrics to support procurement strategies for equipment, inventory management, spares and preventative maintenance. Manage and track changes to specifications and standards, and system configuration.
Design: Ensure adherence to standards and good engineering practices. Lead design of new systems in support of projects and new technology deployment. Ensure designs optimize the total life cycle of the asset, from both a cost and effectiveness standpoint.
Construction: Use their TA 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 their 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 TAs. 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.
This role involves travel up to 30% including overnight stays
Position can be in ATO (Thousand Oaks, CA) or AML (Juncos, Puerto Rico) and we would consider ADL (Ireland)
Master's degree & 3 years of Engineering experience
Bachelor's degree or & 5 years of Engineering experience
Associate's degree & 10 years of Engineering experience
High school diploma / GED & 12 years of Engineering experience
*Master's degree in Engineering, Physical or Life Sciences
* Proven ability to manage and deliver results in a highly fluid, interactive matrixed environment
* 10 years of engineering experience in a site and/or corporate engineering environment, with specific specialized expertise in operations and equipment design for one more of the following areas: Drug Product Formulation and Filling Engineering, Labeling and Packaging, and Inspection Systems.
* 3 years within the pharmaceutical/biotechnology industry; experience to include physical and chemical stability of proteins, and experience in interpreting results from various analytical methods.
* 3 years managing a team (staff development, assigning tasks)
* 3 years of experience in executing engineering projects (cross functional team managing departmental or functional level projects: approving resources, assigning tasks)
* 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