24 days old

Pilot Plant Senior Engineer

Amgen
Thousand Oaks, CA 91360
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  • Job Code
    120748824
Amgen

Job ID: R-99270
Location: Thousand Oaks, CA, US 91360

Amgen is seeking a Senior Engineer for the Upstream Team in Development Supply Chain Pilot Plant in Thousand Oaks, CA. 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.

The successful candidate will support the following team objectives, but other responsibilities may be assigned:
  • Support a safe working environment by aligning with Amgen environmental health/safety standard methodologies, 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 meaningful process requirements and ensure logical, detailed translation of design requirements and constraints into process equipment/system solutions.
  • Handle technology portfolio for Upstream Team. 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 executing experiments on new or modified process equipment to evaluate the performance.
  • Lead evaluation of equipment, instruments and instrumentation for equipment advancement.
  • Lead area automation improvements, collaborating with F&E
  • Lead facility fit assessments (new equipment specification, hazardous waste evaluation, process safety review), including GMP readiness activities.
  • Represent PPN on global teams.
  • Build and execute process flow diagrams as part of product planning. Lead new product introductions (NPIs), as assigned.
  • Develop technical solutions to sophisticated problems requiring the regular use of resourcefulness 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 plants.
  • Perform on-floor process unit operation execution.


Basic Qualifications:

Doctorate degree

OR

Master's degree and 3 years of engineering and/or manufacturing experience

OR

Bachelor's 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:
  • Bachelor's degree in chemical, biochemical, mechanical engineering, or other relevant field
  • 5+ years of meaningful 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.
  • 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.
  • Standout colleague 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, process incidents/non-conformances, corrective and preventative actions, and commissioning and qualification practices.
  • Experience in engineering directly related to bulk biopharmaceutical production, including procurement and qualification.
  • Work schedule flexibility as needed to support process operations, requiring occasional after-hours or weekend coverage.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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.

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.



PI120748824
Posted: 2020-06-09 Expires: 2020-07-11

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Pilot Plant Senior Engineer

Amgen
Thousand Oaks, CA 91360

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