Engineer, Drug Product Technologies & Engineering
AmgenThousand Oaks, CA2 months ago

Career Category

Engineering

Job Description

As part of Amgen’s Process Development organization, Drug Product Technologies & Engineering (DPTE) is seeking a highly motivated Engineer to provide process development support to Amgen’s clinical and commercial aseptic fill-finish manufacturing plant in Thousand Oaks, CA. The candidate will be part of Drug Product Process Engineering team passionate about bringing a wide variety of high-quality clinical and licensed drug products to patients through demonstrated excellence in Technology Transfer, aseptic processing operations, process characterization, process validation and continuous process verification.
The successful candidate will apply process engineering knowledge to support development including:
  • Characterizes drug product process, designs and executes off-line and on-line studies to fully establish process parameter ranges, and enables successful technology transfer.
  • Provides solutions to a variety of technical problems in drug product manufacturing operations with growing scope and complexity, while applying standard engineering techniques/procedures
  • Conducts technical assessments on process/product impact due to changes in equipment, scale and/or raw materials. Supports process related deviations, troubleshooting, exception resolution and root cause analyses to ensure smooth manufacturing operations & continued supply.
  • Represents process development in interactions with manufacturing and support functions such as engineering, quality, validation, regulatory and product teams to provide coordinated support
  • Serves as domain specialist for new drug product manufacturing technologies introduced into the plant and works with global multi-functional teams for shared best practices to optimally integrate into routine operations
  • Supports driving innovation in aseptic processes, technologies and techniques, all in alignment with evolving regulatory expectations and internal quality standards, leading to continuous improvement in GMP drug product manufacturing & authoring high quality regulatory submissions
  • Works with a team of engineers to craft, execute and document primary data packages related to new technology/process development, while demonstrating specific expertise in aseptic processing and unit operations characterization
  • Supports plant expansion projects by supporting equipment user requirements, FAT, Process Characterization and Validation in sterile fill finish processing areas.
  • Utilizes strong written and verbal communication skills re: technical writing and presentations and reviewing GMP documentation
Basic Qualifications:
Master’s degree
OR
Bachelor’s degree and 2 years of Engineering experience
OR
Associate’s degree and 6 years of Engineering experience
OR
High school diploma / GED and 8 years of Engineering experience
Preferred Qualifications:
  • Educational background in Chemical Engineering, Biomedical Engineering, Mechanical Engineering, or related technical field of study
  • Solid understanding of cGMP, drug product process development and manufacturing operations including freeze/thaw, formulation/mixing, filtration, filling, lyophilization, capping, and visual inspection
  • Familiarity with design and analysis of experiments, and statistical analysis
  • Experience in applying fundamental engineering principles to solve technical problems
  • Able to demonstrate technical writing, project management and presentation skills
  • Desire to be a teammate in a dynamic, multi-functional environment
  • Ability to run multiple projects concurrently
  • Excellent Excel / PowerPoint skills
  • Ability to use data analytics and programming skills, as appropriate, to advance digital transformation efforts in aseptic fill finish manufacturing plants
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.
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