Sr. Engineer

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Job description

HOW MIGHT YOU DEFY IMAGINATION?

Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Senior Engineer

Live

What you will do

Lets do this. Lets change the world. In this dynamic role you will ensure reliable equipment and facility performance by improving uptime, and enabling integration of new technologies to advance Amgens clinical and commercial products' supply.

Responsibilities include:

• Provide technical leadership using engineering principles and drive forward projects varying from functional area projects passionate about improving process equipment/utilities/facilities -to- large/complex capital projects to integrate new drug product manufacturing technologies into clinical/commercial facility. Use engineering expertise within the company and industry standard methodologies, 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 multi-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.
• Handle performance of contingent staff that implement work under validation maintenance program. Handle decision making around unplanned priorities (e.g. unbudgeted projects). Ensure readiness and compliance for internal audits, external agency audits, and partner audits. Ensure safety of all personnel during validation maintenance activities. Ensure that all staff are adequately trained and align with all GMP standards and procedures. Develop and adhere to program and operational expense budgets and spend.
• Be knowledgeable about compliance and regulatory aspects for equipment validation, operation and maintenance and support regulatory inspections and audits.

Win

What we expect of you

We are all different, yet we all use our distinct contributions to serve patients. The Engineering professional we seek will possess these qualifications.

Basic Qualifications:

• Doctorate degree OR Masters degree and 3 years of Engineering experience OR Bachelors degree and 5 years of Engineering experience OR Associates degree and 10 years of Engineering experience OR High school diploma/GED and 12 years of Engineering experience

Preferred Qualifications:

• Masters degree in Chemical or Mechanical Engineering
• 6+ years' of relevant work experience with 3+ 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 continuous fill lines (washer, tunnel, isolator, cappers and lyophilization), filling, lyophilization, inspection, device assembly, cell culture reactors, chromatography, filtration as well as other equipment needed to support these processes such as autoclaves, clean in place (CIP) systems, washers, clean steam, water for injection, etc.
• 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 oversight of capital projects
• Understanding of the safety requirements and execution process of capital projects in a GMP Biopharmaceutical Production facility including procurement, construction, startup, and validation
• Organized and collaborative teammate with ability to multi-task
• Strong leadership, technical writing, and communication/presentation skills
• Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage

Thrive

Some of the vast rewards of working here

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

• Full support and career-development resources to expand your skills, enhance your expertise, and improve your potential along your career
• A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply now for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com
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.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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.