Senior Engineer, Final Drug Product Engineer
The Senior Engineer is responsible for planning, design, construction, and operations and maintenance technical support of Amgen manufacturing infrastructure, world-wide for final drug product systems. The Engineering Technical Authority (TA) is responsible for technical direction, leadership, guidance and support for a specific area of process systems and technology. 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 specifically focused on final drug product equipment and processes including device assembly, inspection, labeling and packaging for Amgen's portfolio of products.
This position is in the Process System Engineering team which has global responsibility for equipment engineering support and capital project delivery for Upstream Processes, Downstream Processes, Fill/Finish, CIP/SIP, Utilities and Final Drug Product systems with emphasis network manufacturing engineering and capital project delivery. Responsibilities may include technical network management and other 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. Assessment and identification of standard designs for network alignment.
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: Provide leadership of global network of SMEs to address operational issues and to define standard designs and in support of new technology development and implementation. Support development of operation procedures for the safe, efficient and effective operations of systems. 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 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. Provide mentoring of other members in their network. 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 will be in based Amgen Thousand Oaks, but candidates with preference for location at Amgen's Puerto Rico or Ireland locations will be considered.
Master's Degree and 3 years of Engineering or Operations experience
Bachelor's Degree and 5 years of Engineering or Operations experience
Associate's degree and 10 years of Engineering or Operations experience
High school diploma/GED and 12 years of Engineering or Operations experience
- EIT (Engineer in Training) or PE (Professional Engineer)
- 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 Substance - upstream, downstream, and/or ancillary equipment; Specific expertise in the area of single use process equipment design and operation
- 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
We understand that to successfully sustain and grow as a global enterprise and deliver for patients - we must ensure a diverse and inclusive work environment.
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 brea
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.