As an Engineer in the Drug Substance Technology & Engineering Team, you will be responsible for the technology transfer and commercial support of biologics drug substance purification processes across the network, including both the Amgen manufacturing network and/or Contract Manufacturing Organizations. You will work as a member of a team of engineers and scientists as you use engineering principles to implement purification manufacturing processes in a cGMP environment.
SPECIFIC RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:
Provide solutions to a variety of technical problems of moderate scope and complexity.
Under general supervision will evaluate, select and apply standard engineering techniques and procedures. Assistance given for unusual problems.
Perform assignments that have clear and specific objectives and require investigation of limited number of variables.
Initiate and complete routine technical tasks.
Function as a technical expert to equipment or systems regarding troubleshooting operations. Frequently become actively involved in daily operations when required to meet schedules or to resolve complex problems.
Routinely monitor purification manufacturing processes for performance indicators and operations. Suggest problem resolution and provide troubleshooting guidance.
Apply engineering principles and statistical analysis, including design of experiments, in-order to solve processing issues and evaluate opportunities for process improvements
Work with Research, Manufacturing, Maintenance, Process Development, Utilities, Facilities, Quality Assurance, and/or Validation departments in developing requirements and recommendations for processes and/or system modifications.
Work under the direct supervision of project managers to complete design, engineering, and construction projects within schedule and budget constraints.
Work with consultants, architects, and engineering firms on development of standard design documents.
Communicate and collaborate with technical and management staff within Manufacturing, Process Development, and Quality departments.
Support non-standard shift organization and extended hours, as per business needs.
Bachelor’s degree and 2 years of Engineering or Operations experience
Associate’s degree and 6 years of Engineering or Operations experience
High school diploma / GED and 8 years of Engineering or Operations experience
Education background in Chemical Engineering, Bioengineering or Biotechnoloy
2+ years of experience in a Process Development/Process Engineering environment, with specific experience in the implementation and support of biopharmaceutical purification manufacturing processes.
Experience in purification process scale-up and technology transfer from laboratory to pilot and/or manufacturing scale
Experience working with commercial manufacture of biologics using single-use technology
Basic understanding of cGMP requirements
Experience related to downstream biologics process development technology transfer, scale-up and ongoing manufacturing of biologics (cGMP). This includes technical support for nonconformance investigations and other commercial support activities
Experience working with design and optimization of pharmaceutical processing unit operations including clarification, chromatography (affinity, IEX, HIC, SEC, etc.), TFF, and sterile filtration among others for a variety of biological molecules
Experience analyzing data generated from a variety of analytical techniques
Regulatory knowledge and interactions
Project management skills
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.