29 days old

Senior Engineer - Final Product Technology

Amgen
Thousand Oaks, CA 91360
  • Job Code
    116463954
Amgen

Job ID: R-90180
Location: Thousand Oaks, CA, US 91360

Would you like to work with a highly motivated team of engineering professionals to positively impact patients' lives? Amgen is seeking a Senior Engineer for the Final Product Technology team to be responsible for the application of diverse and advanced engineering principles (mechanical and materials science). The Sr. Engineer will design, optimize, characterize, and troubleshoot the deployment of primary container systems (including oral dosage forms) in a GMP aseptic environment.

Additional responsibilities include:

  • Lead primary component technical activities within Process Development and external partners
  • Determine User Requirement Specifications of primary container closure systems for new and existing Amgen products
  • Provide hands-on technical leadership on primary component issues related to customer complaints, aseptic filling, lyophilization and inspection operations for the manufacture of commercial biopharmaceuticals
  • Support development of characterization methods for mechanical and physical properties of primary components
  • Support integration of primary containers into new and existing devices
  • Support on-going NC/CAPAs and Change Control
  • Collaborate extensively with internal and external project teams, i.e. manufacturing, vendors, quality, regulatory, etc.


This position will operate in a highly matrixed environment and collaborate with multi-functional teams, communicate and elevate technical or strategic issues to team members and management and make recommendations and/or decisions to guide successful execution of process transfers.

Basic Qualifications:

Doctorate degree

Or

Master's degree and 3 years of Engineering or Life Sciences experience

Or

Bachelor's degree and 5 years of Engineering or Life Sciences experience

Or

Associate's degree and 10 years of Engineering or Life Sciences experience

Or

High school diploma / GED and 12 years of Engineering or Life Sciences experience

Preferred Qualifications:

  • M.S. or Ph. D. in Materials Science, Chemical Engineering or Mechanical engineering
  • 3+ years of experience in the Pharmaceutical/Biotechnology industry
  • Aseptic fill/finish experience
  • Experience with cGMPs, regulatory filings and compliance issues for sterile injectable products manufactured by aseptic processing; as well as oral dosage forms (solid and liquid)
  • Excellent written and verbal communication experience combined with demonstrated ability to work in a team environment
  • Project management experience including the ability to coordinate and communicate across different functions and sites in order to successfully complete projects
  • Experience including statistical analysis and design of experiments, process characterization, scale-up, and/or technology transfer
  • Experience leading, deploying or using Operational Excellence principles and tools (eg. HRP, Lean Six Sigma etc.)
  • Ability to travel to international locations assisting our development partners during implementation of specific container requirements into their processes


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.

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.

PI116463954

<b>Amgen</b><br/><br/><b>Job ID: </b>R-90180<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>Would you like to work with a highly motivated team of engineering professionals to positively impact patients' lives? Amgen is seeking a Senior Engineer for the Final Product Technology team to be responsible for the application of diverse and advanced engineering principles (mechanical and materials science). The Sr. Engineer will design, optimize, characterize, and troubleshoot the deployment of primary container systems (including oral dosage forms) in a GMP aseptic environment.<br><br><b><b>Additional responsibilities include:</b></b><br><br><ul><li>Lead primary component technical activities within Process Development and external partners</li><li>Determine User Requirement Specifications of primary container closure systems for new and existing Amgen products</li><li>Provide hands-on technical leadership on primary component issues related to customer complaints, aseptic filling, lyophilization and inspection operations for the manufacture of commercial biopharmaceuticals</li><li>Support development of characterization methods for mechanical and physical properties of primary components</li><li>Support integration of primary containers into new and existing devices</li><li>Support on-going NC/CAPAs and Change Control</li><li>Collaborate extensively with internal and external project teams, i.e. manufacturing, vendors, quality, regulatory, etc.</li></ul><br><br>This position will operate in a highly matrixed environment and collaborate with multi-functional teams, communicate and elevate technical or strategic issues to team members and management and make recommendations and/or decisions to guide successful execution of process transfers.<br><br><b><b>Basic Qualifications:</b></b><br><br>Doctorate degree<br><br>Or<br><br>Master's degree and 3 years of Engineering or Life Sciences experience<br><br>Or<br><br>Bachelor's degree and 5 years of Engineering or Life Sciences experience<br><br>Or<br><br>Associate's degree and 10 years of Engineering or Life Sciences experience<br><br>Or<br><br>High school diploma / GED and 12 years of Engineering or Life Sciences experience<br><br><b><b>Preferred Qualifications:</b></b><br><br><ul><li>M.S. or Ph. D. in Materials Science, Chemical Engineering or Mechanical engineering</li><li>3+ years of experience in the Pharmaceutical/Biotechnology industry</li><li>Aseptic fill/finish experience</li><li>Experience with cGMPs, regulatory filings and compliance issues for sterile injectable products manufactured by aseptic processing; as well as oral dosage forms (solid and liquid)</li><li>Excellent written and verbal communication experience combined with demonstrated ability to work in a team environment</li><li>Project management experience including the ability to coordinate and communicate across different functions and sites in order to successfully complete projects</li><li>Experience including statistical analysis and design of experiments, process characterization, scale-up, and/or technology transfer</li><li>Experience leading, deploying or using Operational Excellence principles and tools (eg. HRP, Lean Six Sigma etc.)</li><li>Ability to travel to international locations assisting our development partners during implementation of specific container requirements into their processes</li></ul><br><br>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.<br><br>Join Us <br> <br> 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. <br> <br> 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. <br> <br> 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. <br> <br> 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.<br/><br/> <img src="https://analytics.click2apply.net/v/yg7JPJF6pQXmFkAdFGNVO"> <p>PI116463954</p>

Categories

Posted: 2019-12-19 Expires: 2020-01-19

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Senior Engineer - Final Product Technology

Amgen
Thousand Oaks, CA 91360

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast