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Senior Engineer

Employer
Amgen
Location
Cambridge, MA
Start date
Sep 15, 2022
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Job Details

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.

Senior Engineer

Live

What you will do

Lets do this. Lets change the world. In this vital role you will work for the Scale Up Lab (SUL) in the Manufacturing Clinical Supply Pilot Plant in Cambridge, MA! As part of a Pilot Plant Network (PPN), this Pilot Plant leads Amgen into the future by identifying, evaluating, developing, and implementing impactful, innovative, new process equipment technologies in the drug substance (DS) pilot plants and assisting with facilitating implementation into clinical manufacturing.

Responsibilities:
  • Support a safe working environment by complying with Amgen environmental health/safety best practices, and industry regulations.
  • Provide project and technical support to partner groups (as needed) for department projects, of medium to high complexity, as a bioprocessing subject matter expert (SME).
  • Partner closely with the pre-pivotal and pivotal development groups to identify significant process requirements and ensure logical, systematic translation of design requirements and constraints into process equipment/system solutions.
  • Lead technology portfolio and capital projects/equipment procurement for Scale-Up Lab. Prepare and present project updates to technical teams and management.
  • Develop and mature new process and process equipment technologies from proof of concept through to GMP clinical/commercial manufacturing, by designing and carrying out experiments on new or modified process equipment to evaluate the performance.
  • Lead evaluation of equipment, instruments, and instrumentation for equipment advancement.
  • Lead facility fit assessments (new equipment specification, hazardous waste evaluation, process safety review), including GMP readiness activities.
  • Represent PPN on global teams.
  • Create and manage process flow diagrams as part of product planning. Lead new product introductions (NPIs), as assigned.
  • Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity
  • Lead implementation of key department goals and initiatives, including advancement of data visualization
  • Support the Lean Manufacturing by leading equipment-related investigations (performing problem solving and root cause analysis investigations) of process and safety events in the pilot
  • Perform on-floor process unit operation execution.
  • Lead automation projects, strategies, and troubleshooting
  • Work schedule flexibility to support process operations, occasional after-hours or weekend
  • Equipment owner: Onboard assets in Maximo with partner groups, scheduling and coordinating calibration activities, participating in maintenance activities as needed, implementing CCs and CAPAs
Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is a collaborative partner with these qualifications.

Basic Qualifications:

  • Doctorate degree or
  • Masters degree and 3 years of engineering and/or manufacturing experience or
  • Bachelors degree and 5 years of engineering and/or manufacturing experience or
  • Associates degree and 10 years of engineering and/or manufacturing experience or
  • High school diploma / GED and 12 years of engineering and/or manufacturing experience.
Preferred Qualifications
  • Bachelors degree in chemical, biochemical, mechanical engineering, or other relevant field
  • 5+ years of relevant work experience in a pharmaceutical/biopharmaceutical engineering role including 1+ years of experience in an operations/ manufacturing environment.
  • Ability to demonstrate knowledge/proficiency in mammalian cell culture, recovery, and/or protein purification.
  • Ability to read and understand engineering drawings (e.g. P&IDs, PFDs, GAs, Electrical Schematics) and ability to draft and develop P&IDs and PFDs.
  • Experienced with single use process systems
  • Project support and design experience.
  • Knowledge of Lean Manufacturing principles.
  • Basic understanding of industry regulations and experience with regulated environments (e.g.cGMP, OSHA, EPA, ASME BPV, ASME BPE etc.).
  • Hands-on experience with manufacturing process equipment, including advanced troubleshooting, reliability and performance improvements, and design optimization.
  • Basic understanding or familiarity with Maximo asset management system
  • Experience in DeltaV automation (operation, solving, and preliminary design)
  • Leadership, technical writing, and communication/presentation skills.
  • Independent, self-motivated, organized, able to multi-task and change with adapting priorities in a fast-paced operational support environment.
  • Team player who is prepared to work in and embrace a team-based culture that relies on collaboration with peers and clients for effective results in a highly dynamic environment.
  • Experience with change control, commissioning and qualification practices, process incidents/non-conformances, corrective and preventative actions, and root cause analysis.
  • Experience in engineering directly related to bulk biopharmaceutical production, including Procurement, commissioning, and qualification.
Thrive

What you can expect of us

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.

  • 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.

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, 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.

Company

We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.

We live the mission.

We win together.

We thrive on continual challenge.

Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.

At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.

Connect with us to explore how you can Win, Live, and Thrive at Amgen.

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Find Us
Website
Phone
805-447-1000
Location
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States
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