Amgen

Senior Engineer - B30 Pilot Plant Engineering

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Sep 08, 2019
Ref
R-81298
Required Education
High School or equivalent
Position Type
Full time
Amgen is seeking a Senior Plant Engineer at its main headquarters in Thousand Oaks, CA to join the GMP Facilities and Engineering (F&E) organization. This position will report to the Senior Manager of Engineering and will provide engineering support primarily for the B30 Pilot Plant Facility.

Responsibilities
  • Lead a team of engineers and/or external workers to ensure the B30 Pilot Plant process equipment is ready and performs reliably.
  • Identify and implement engineering-based improvements or upgrades to the upstream and downstream process equipment. This includes identification of design requirements, options analysis, design, installation, startup, and qualification of equipment.
  • Perform the system owner role for assigned systems to ensure equipment reliability and compliance. This includes specifying and overseeing a properly executed preventive maintenance program.
  • Support equipment maintenance as necessary to ensure systems are in proper working order.
  • Ensure the necessary commissioning and qualification of systems in partnership with C&Q team and interact with auditors as needed.
  • Monitor systems to identify performance risks and implement risk reduction strategies.
  • Provide troubleshooting support to reduce production downtime. This may involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action.
  • Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and developing new technologies in partnership with Technology Development Team.
  • Ensure systems are installed and operating safety and comply with pertinent environmental health/safety practice, rules and regulations.
  • Up to 10% domestic travel.


Basic Qualifications

Doctorate degree

OR

Master's degree and 3 years of Engineering experience

OR

Bachelor's degree and 5 years of Engineering experience

OR

Associate's degree and 10 years of Engineering experience

OR

High school diploma / GED and 12 years of Engineering experience

Preferred Qualifications
  • Bachelor's degree in Chemical or Mechanical Engineering
  • 6+ years' of relevant work experience with 5+ years' experience in Biopharmaceutical operations/manufacturing environment
  • Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.) and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation
  • Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems such as cell culture reactors, chromatography, filtration, as well as other equipment needed to support these processes such as autoclaves, clean in place (CIP) systems, washers, clean steam, water for injection, etc.
  • Ability to analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g., Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.)
  • Experience applying engineering principles to the design and implementation of system modifications, introduction of new processes, and execution of capital projects
  • Understanding of the execution process of capital projects in a GMP Biopharmaceutical Production facility including procurement, construction, startup, and validation
  • Understanding of safety and quality requirements working in a GMP Biopharmaceutical Production facility.
  • Independent, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration
  • Team player prepared to work in and embrace a team based culture that relies on collaboration for effective decision-making
  • Strong leadership, technical writing, and communication/presentation skills
  • Work schedule flexibility to support 24/7 operations, requiring occasional after-hours engineering coverage as required from time to time


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.

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.