Amgen Senior Engineer in Thousand Oaks, California
Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against osteoporosis, cancer, migraines, cardiovascular disease, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives.
Amgen is seeking a Senior Engineer for the Engineering Technologies Team in Development Supply Chain Facilities and Engineering. The Engineering Technologies Team 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 clinical manufacturing.
The successful candidate will support the following team objectives:
Supporting and driving the project funding process and providing project and technical leadership for small to medium size department capital projects in the three DS pilot plants as bioprocessing subject matter experts (SME).
Drive and support the large construction projects in pilot and clinical plants, by partnering with Global Capital Project Management and Corporate Engineering. During project execution, the candidate will provide SME input and advanced process equipment technical design support.
Provide plant engineering support for day to day operations in the B30 pilot plant, including establishing and maintaining pre-pivotal GMP readiness of process equipment.
Support the Lean Manufacturing program and problem solving and root cause analysis investigations of process and safety events in the pilot plants.
Develop and mature new process and process equipment technologies from proof of concept through to GMP clinical/commercial manufacturing by applying the right degree of rigor for each phase of implementation, increasing GMP readiness along the way.
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.
Support a safe working environment by complying with environmental health/safety practices, rules and regulations.
Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.
Design and execute experiments on new or modified process equipment to evaluate the performance of new or improved technologies.
Present results to technology teams and management.
Represent pilot and clinical operations within key corporate networks and teams
Lead implementation of key department goals and initiatives.
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.
Bachelor's degree in chemical, biochemical, or Mechanical Engineering
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 in mammalian cell culture, recovery and 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.
Capital 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, prepared to work in and embrace a team-based culture that relies on collaboration with peers and clients for effective results.
Experience with change control, process incidents/non-conformances, corrective and preventative actions, and qualification practices.
Experience in design and startup engineering directly related to bulk biopharmaceutical production including facility design, procurement, construction, startup, and qualification.
Work schedule flexibility as needed to support 24/7 operations, requiring occasional after-hours or weekend engineering coverage.
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.