The Engineer supports manufacturing activities associated with cGMP equipment, process and facilities at Amgen Thousand Oaks (ATO). It will provide technical support to complex engineering equipment and processes. Entry level experience in design, qualification, operation, maintenance and improvement of biopharmaceutical equipment will be required to support day to day manufacturing activities as well as to participate in improvement projects. Applies diverse engineering principles to the design and implementation of major system modifications, process and/or capital projects. The Engineer works in partnership with the Maintenance, Project Management, Engineering Technical Lead, and Manufacturing to develop and oversee the operation and reliability of equipment. The Engineer will work closely with Quality Assurance (QA) for GMP compliance. In addition, the Engineer will support periodic review of manufacturing systems to ensure that they remain in a validated state. The engineer will support the projects in defining strategies for quality systems verification and will work with the process development / validation team to develop and document appropriate practices for characterization.
- Assist in the identification of critical quality parameters and process attributes for new equipment or facility modifications.
- Assist in development and review of User Requirements Specifications (URS).
- Suggest design modifications to address risks and design in quality and safety.
- Organizes, analyses and presents interpretation of results for operational issues or engineering projects of significant scope and complexity.
- Perform basic troubleshooting of equipment failures or malfunctions and/or the development of technical assessments.
- Recommend, evaluate, and manage performance of contract resources
- Provide oversight for verification deliverables developed by outsourced/contract verification staff.
- Act as a liaison between Engineering and Quality Assurance during project planning, execution, and closeout
- Ensure that validation protocols are executed and documented in accordance with cGMP good documentation and safety compliant practices.
- Ensure safety during commissioning, validation, maintenance and manufacturing activities
- Support Manufacturing and QA with Performance Qualification (PQ) activities.
Bachelor's degree and 2 years of Engineering and/or Manufacturing experience
Associate's degree and 6 years of Engineering and/or Manufacturing experience
High school diploma / GED and 8 years of Engineering and/or Manufacturing experience
- Bachelor's degree in engineering or another science-related field
- 5+ years' experience in operations/manufacturing environment
- Direct experience with regulated environments (FDA, OSHA, EPA, etc.)
- Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, clean utilities, facilities, instruments and equipment
- Experience implementing risk-based verification on major GMP process equipment / automation projects, including validation protocol development and execution
- Basic knowledge in the design of maintenance and reliability activities such as job plan, data sheets and equipment reliability technology.
- Process equipment knowledge - cell culture, purification,
- Process automation knowledge
- Knowledge of Delta V, Rockwell, and Plant Information Systems
- Experience in developing SOPs and delivering training
- Proven track record of applying process improvement methodologies to mature and improve business processes (e.g. PDCA, LEAN, Six Sigma, and fundamental understanding of statistics, etc.)
- Demonstrate project management skills and application of concepts.
- General knowledge on Biopharmaceutical equipment operations and processes such as single use technologies, Media / Buffer Prep solutions, Inoculation, Bioreactors, Harvest, Chromatography and Tangential Flow Filtration as well as Clean Utilities.
- Experience in investigation of deviations, development of corrective and preventive actions and generation and implementation of change controls.
- Flexibility to work off-hours.
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.