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Job Details


Amgen

Engineering Manager (Drug Substance Plant Engineering) (R-148825)

Pharmaceuticals

All

Yearly

No

Thousand Oaks, California, United States

HOW MIGHT YOU DEFY IMAGINATION?

You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. 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, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Engineering Manager

Live

What you will do

Let’s do this. Let’s change the world. In this dynamic role you will provide leadership to the engineering team to ensure reliable equipment and facility performance for a Biopharmaceutical Production facility.

Responsibilities include:

  • Provide technical leadership to a team of manufacturing support engineers/project engineers supporting commercial and clinical production operations with emphasis on Drug Substance bioprocessing equipment. The Engineering Manager position will report to the Senior Manager of Engineering.
  • Deliver long term Engineering strategic improvement initiatives for the plant.
  • Establish clear expectations and priorities to staff. Encourage a culture of continuous improvement, partnership, and knowledge sharing. Provide development opportunities, feedback, and actively listen to staff.
  • Cultivate a culture of safety ensuring the well-being of all staff members and drive efforts to reduce safety risks.
  • Provide technical support to troubleshoot, identify and resolve process and system issues as needed and manage engineering project delivery portfolio.
  • Prioritize and manage equipment and system improvement projects as well as deliver Capital Projects related to responsible area.
  • Be knowledgeable about compliance and regulatory aspects for equipment validation, operation and maintenance and support regulatory inspections and audits. Ensure readiness and compliance for internal audits, external agency audits, and partner audits.
  • Own the development and implementation of the equipment and systems reliability program.
  • Effectively collaborate with key customers and support groups (e.g. Manufacturing, Quality, Process Development, Maintenance, network partners).
  • Active participation in daily manufacturing and maintenance team meetings.
  • Develop and implement departmental execution plans that are aligned with the broader organizational strategy.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.

Basic Qualifications:

  • Doctorate degree OR
  • Master’s degree with 3 years of Engineering and Operations experience OR
  • Bachelor’s degree with 5 years of Engineering and Operations experience OR
  • Associate’s degree and 10 years of Engineering and Operations experience AND
  • Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications:

  • Bachelor’s or Master’s degree in Chemical or Mechanical Engineering
  • Previous experience managing or leading technical teams
  • 6+ years' of relevant work experience with 3+ years' experience in Biopharmaceutical operations/manufacturing environment
  • Experience working in a regulated environment (e.g. cGMP, FDA, 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 bioreactors, centrifuges, chromatography, filtration equipment such as tangential flow, viral and depth filtration, mixing tanks, instrumentation, autoclaves, clean in place (CIP) systems, parts washers, etc. Experience with both stainless steel and single use equipment is preferred.
  • Ability to analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses.
  • 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 working in a GMP Biopharmaceutical Production facility
  • 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, we also 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 maximize your potential along your career journey
  • A 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—with 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.

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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, Puerto Rico and Canada 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.