Senior Engineer - Single Use Technologies
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.
Senior Engineer - Single Use TechnologiesLive
What you will do
Let’s do this! Let’s change the world! In this vital role, you will be part of the Drug Substance Technology and Engineering group within the Process Development organization. One of the primary responsibilities will be providing technical leadership for Single Use components and assemblies. In this role, you will also introduce new technologies to the network and will be supporting investigations of Amgen's global manufacturing.Other Key Responsibilities Include:
- Use process engineering and equipment design experience, to assess unit operation performance and work with both suppliers and the internal network to resolve equipment and single use consumable challenges.
- Analyze available data, research technical subjects, and work with other subject matter experts to support resolution of critical investigations.
- Provide leadership on capital projects.
- Provide process development representation on capital projects, ensuring process requirements are incorporated into equipment and facility designs.
- Support and/or lead design of flexible manufacturing equipment and single use consumables, including support of factory acceptance testing and onsite commissioning and qualification.
- Support the Amgen single use global network as a drug substance domain expert.
- Provide leadership on various work streams related to improving robustness of design, specification, and qualification of single use consumables and equipment.
- Lead technical assessments for supplier and internally inspired changes, evaluating impact to fit and function.
- May support technical visits to evaluate capabilities of current and potential suppliers, and assess new technologies that could provide cost, throughput, or other unique capabilities to Amgen manufacturing.
This role will be mostly remote, with the occasional need to be on site. The person in this position is required to be located within 100 miles of Cambridge, MA or Thousand Oaks, CA.Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The detail oriented professional we seek is a highly skilled problem solver with these qualifications.
- High school diploma/GED and 12 years of Engineering or Operations experience OR
- Associate’s degree and 10 years of Engineering or Operations experience OR
- Bachelor’s degree and 5 years of Engineering or Operations experience OR
- Master’s degree and 3 years of Engineering or Operations experience OR
- Doctorate degree
- Master’s degree and 6+ years of directly related experience, or PhD with 2+ years of directly related experience
- Strong understanding of GMP equipment design and biologics manufacturing requirements
- Detailed knowledge of multiple unit operations
- Experience leading root cause analyses and solving GMP manufacturing issues
- Ability to apply sophisticated problem solving skills within defined constraints
- Experience providing process engineering support of pilot/clinical/commercial processes
- Experience with large capital projects, including design, procurement, commissioning and qualification of production scale equipment
- Experience with single-use component design and application in biopharmaceutical production
- Experience developing and transferring process technology into GMP production environment
- Excellent technical writing and verbal communication skills
- Excellent facilitation and influencing skills
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
for a career that defies imagination
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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.