The Principal Engineer will be joining Facilities & Engineering (F&E) group within Development Supply Chain organization at Amgen. The group's mission is to enable introduction and integration of new technologies while ensuring existing clinical and commercial facilities and equipment operate reliably. This position will report into Senior Manager of Engineering supporting drug product supply at Amgen Thousand Oaks site.
- Provide technical leadership using engineering principles and drive forward projects varying from functional area projects focused on improving process equipment/utilities/facilities -to- large/complex capital projects to integrate new drug product manufacturing technologies into clinical/commercial facility. Leverage engineering expertise within the company and industry best practices, compliance with pertinent environmental health and safety practices, and aligning with evolving regulatory expectations and internal quality standards to implement new equipment and/or equipment/utility/facility modifications.
- Provide Commissioning & Qualification (C&Q) leadership to project teams to drive forward C&Q efforts for small projects ( $3M) e.g. facility construction, new equipment integration into clinical/commercial facility. This includes ensuring effective communication flow between cross-functional teams (e.g. F&E, Manufacturing, Quality, Project controls, project management, EHSS) and functional management, leading the selection of contractors for C&Q execution, managing their training and performance, C&Q deliverables and schedule to meet project timelines, and ensuring compliance with Amgen safety, C&Q and Quality standards.
- Manage the portfolio of improvement/innovation projects within the F&E drug product engineering group using strategic approaches and resource prioritization.
- Serve as SME in drug product process equipment, mentor peers in complex problem solving, driving best practices and technical advancement
- Lead Class 2 Non-conformance investigations tied to equipment performance in a cross-functional team setting involving engineering, maintenance, manufacturing, process development, quality.
- Manage NCs/CAPAs within the plant engineering team to ensure appropriate actions are identified in the records to address the root causes as well as on-time closure of the records
- Establish and maintain strategic partnerships with equipment vendors as well as Amgen Network to stay informed on new equipment technologies and ancillary instruments/safety interlocks systems to identify opportunities, assess and implement innovation
- Be knowledgeable about compliance and regulatory aspects for equipment validation, operation and maintenance and support regulatory inspections and audits.
Doctorate degree and 2 years of Engineering experience
Master's degree and 6 years of Engineering experience
Bachelor's degree or and 8 years of Engineering experience
Associate's degree and 10 years of Engineering experience
High school diploma / GED and 12 years of Engineering experience
- Bachelor's degree in Engineering (Chemical or Mechanical), Biotechnology
- 6+ years' of relevant work experience with 5+ years' experience in Biopharmaceutical operations/manufacturing environment
- Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.) and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation
- Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems such as filling (T/P as well as peristaltic), isolators, lyophilization, cappers, inspection as well as other equipment and utilities needed to support these processes such as autoclaves, clean in place (CIP) systems, washers, tunnels, clean steam, water for injection, etc. Knowledge of SU systems and assemblies.
- Ability to analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g., Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.)
- Experience applying engineering principles to the design and implementation of system modifications, introduction of new processes, and execution of capital projects
- Understanding of the execution process of capital projects in a GMP Biopharmaceutical Production facility including procurement, construction, startup, and validation
- Understanding of safety requirements working in a GMP Biopharmaceutical Production facility.
- Independent, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration
- Team player prepared to work in and embrace a team based culture that relies on collaboration for effective decision-making
- Strong leadership, technical writing, and communication/presentation skills
- Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage
- Up to 10% domestic/international travel
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.