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Amgen Sr Engineer - Tech Dev in Thousand Oaks, California

We have a position available for a Senior Engineer to join our Drug Substance Advanced Technology team, part of the Manufacturing and Clinical Supply organization at the Amgen headquarters in Thousand Oaks, CA. This position is to provide insight and leadership in the assessment, design, procurement, and delivery of high performance and flexible drug substance (DS) manufacturing equipment and associated technologies to benefit patients with new medicines at reduced costs while giving Amgen an environmentally sustainable and competitive edge. The highly motivated candidate will use creative thinking along with the application of engineering principles to perform job functions, leveraging technical skills, prior experience, and the ability to coordinate and communicate across diverse teams to mold the future of manufacturing in the biotech industry.

Day to Day Responsibilities:

  • Lead or work with teams in design, development and selection of new DS systems, instruments, and consumable components.

  • Evaluate capabilities of current and potential suppliers, and assess new technologies that could provide cost, throughput, or other unique capabilities to Amgen manufacturing.

  • Deliver capital projects in accordance with company procedures to ensure they are completed on schedule and within established budget.

  • Employ engineering skills and practices to gather user requirements and translate them into technical documentation for execution.

  • Ensure new systems are designed and constructed in a quality fashion per user requirements, design codes, and safety standards.

  • Provide subject matter expert support for the development and troubleshooting of DS processes, operations, and equipment.

  • Perform field evaluations of existing systems and provide engineering recommendations for design improvements.The Sr. Engineer will be encouraged to keep current on the latest industrial, scientific and regulatory trends in order to develop the most competitive and innovative drug substance manufacturing technologies with industry leading capability. This role provides a great opportunity for significant career development in areas of leadership, teamwork, collaboration, communication and to develop network influence by partnering with colleagues in Process Development, Corporate Engineering, and Manufacturing, as well as Quality and Information Systems.

Basic Qualifications

  • Doctorate degree OR

  • Master’s of Science degree in Biochemical, Chemical, Mechanical or Process Engineering, and 3 years of Engineering or Operations experience OR

  • Bachelor’s of Science degree in Biochemical, Chemical, Mechanical or Process Engineering, and 5 years of Engineering or Operations experience

Preferred Qualifications

  • 6+ years of experience in drug substance process development, characterization and/or commercial process support

  • Detailed knowledge of multiple unit operations across DS manufacturing (Cell Culture Scaleup, Perfusion, Centrifugation, Chromatography, Virus Inactivation, Virus Filtration, Tangential Flow Filtration, Normal Flow Filtration, and Clean-In-Place systems)

  • Comprehensive understanding of Good Manufacturing Practices (GMP) equipment design and biologics manufacturing requirements in accordance with the following agencies and codes: OSHA (including obtaining inspection and listed certification via NRTL), ASME B&PV, ASME BPE, NFPA 70E/79, NEC

  • Demonstrated understanding of process engineering principles for the scale up of unit operations from bench to commercial scale.

  • Knowledge of mechanical and material science principles pertaining to stainless and single-use applications in biopharmaceutical production

  • Project management experience including the ability to coordinate and communicate across different functions and sites in order to advance complex projects to completion

  • Experience leading or supporting large capital projects, including design, procurement, commissioning and qualification of production scale equipment

  • Ability to build and maintain high-performing, multi-functional partnerships, manage project resources, and elevate relevant issues to project lead and management

  • Experience conducting system hazard analysis (HAZOP), layer of protection analysis (LOPA), and failure mode and effect criticality analysis (FMECA).

  • Ability to apply innovative thinking, engineering principles, and statistical analysis, including design of experiments, in-order to solve processing or equipment design issues and evaluate opportunities for improvement

  • Experience conducting root cause analyses and troubleshooting equipment, instrumentation, or manufacturing process related issues

  • Experience developing and transferring process technology into GMP production environment

  • Ability to work under minimal direction on multiple projects in a deadline driven environment.

  • Excellent facilitation and technical writing skills

  • Excellent verbal communication and interpersonal skillsAmgen 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. About Amgen Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science’s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics has changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives.

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Equal Opportunity Statement

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.

Join Us

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.

Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.

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