Location Thousand Oaks, CA, US
Posted Jun 19, 2020
Discipline Engineering, Biomedical Engineer, Chemical Engineer, Mechanical/Manufacturing Engineer, Manufacturing & Production, Manufacturing/Mechanical, Process, Supply Chain
Hotbed Biotech Beach, Ideal Employer
Required Education High School or equivalent
Position Type Full time
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Amgen is seeking a Senior Engineer for the Downstream 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 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 meaningful process requirements and ensure logical, systematic translation of design requirements and constraints into process equipment/system solutions.
Manage technology portfolio for Downstream 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, interfacing 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.
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 plants.
Perform on-floor process unit operation execution.
Master’s degree and 3 years of engineering and/or manufacturing experience
Bachelor’s degree and 5 years of engineering and/or manufacturing experience
Associates degree and 10 years of engineering and/or manufacturing experience
High school diploma / GED and 12 years of engineering and/or manufacturing experience.
Bachelor’s 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.
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, 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.
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.
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