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Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.

Principal Engineer

We have a position available for a Principal 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 own the identification, assessment, design, procurement, and implementation of dedication, efficient, and flexible drug substance (DS) manufacturing equipment and associated technologies; benefitting patients with new medicines at reduced costs while giving Amgen an environmentally sustainable and driven edge. The highly motivated candidate will demonstrate process manufacturing experience paired engineering abilities, excellent communication, and an innovative vision to lead teams with varied strengths, advance capital projects, support corporate technical networks, conduct experiments, and develop technologies molding the future of manufacturing in biotech.

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 domain 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 Principal Engineer will be encouraged to keep current on the latest industrial, scientific and regulatory trends in order to develop the most driven and innovative drug substance manufacturing technologies with industry leading capability.

• While the future impact of COVID-19 cannot be known, this role is currently conducted on site from the office or lab when needed, and from home the remainder of the time. Travel is currently limited. Pre-pandemic travel for this role was estimated at 5-15% for training/symposiums, vendor site visits, FAT/startups, or investigation support.

Basic Qualifications

• Doctorate degree and 2 years of engineering experience OR
• Master’s degree and 6 years of engineering experience OR
• Bachelor’s degree and 8 years of engineering experience OR
• Associate’s degree and 10 years of engineering experience OR
• High school diploma / GED and 12 years of engineering experience

Preferred Qualifications

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

• Detailed knowledge and direct experience with 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 sophisticated 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 hard-working, multi-functional partnerships, lead 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 solving problems 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 social skills

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 spectacularly improve people’s lives.

Thrive

What you can expect of us

As we work to develop treatments that look after others, so we work to care for our teammates’ professional and personal growth and well-being.

• Vast opportunities to learn and move up and across our global organization

• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Apply now for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

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