23 days old

Principal Engineer

Amgen
Thousand Oaks, CA 91360
  • Job Code
    115545265
Amgen

Job ID: R-87798
Location: Thousand Oaks, CA, US 91360
Additional Location: US - Puerto Rico - Juncos

The Principal Engineer in Process Development (PD) will report to the Director of Packaging Engineering and Labeling, and will be located in Thousand Oaks, California.

The successful candidate for this position will lead a team of engineers responsible for the clinical and commercial packaging for drug substance, drug product, primary container closures and final product presentations. The candidate will help create and implement the long-term strategy to ensure that Amgen becomes and remains an industry leader in this area. They will work cross functionally as a Device Technology Lead (DTL) within PD and across Amgen to develop products that create a successful patient experience.

The Principal Engineer is expected to develop annual goals and strategic direction for the packaging organization to the Final ProductTeamLead(FPTL). The Principal Engineer will identify and drive efficiencies and utilization of the commercialization process, the lifecycle of products, and the overall manufacturing capability of Amgen operations across the global networks.

Responsibilities Include:
  • Design, qualification and implementation of packaging designs
  • Pursue packaging technologies that will drive innovation and gain efficiencies in the network
  • DTL lead for molecule programs driving packaging strategy and milestone to the PDT
  • Consistently deliver results aligned with departmental and program goals.
  • Drive continuous improvement in the packaging processes from project initiation through launch as well as life cycle management. In alignment with regulatory and commercial manufacturing requirements.
  • Develop and maintain a high performing team of engineers, with advanced degrees and experience in packaging engineering that are professionally and technically competent.
  • Be a role model in living the Amgen values and leadership attributes.
  • Identify resource requirements to deliver on program portfolio and negotiate resource assignments from leadership.
  • Deliver progress reports and presentations ensuring that management is aware of the current status, progress and future needs within Operations.
  • Identify and ensure area of responsibility complies with the most current standards and company policies.
  • Author regulatory documents in support of molecule applications.
  • Provide leadership and guidance to ensure consultants, contract manufacturers, and external business partners comply with business standards and requirements.


Basic Qualifications:

Doctorate degree and 2 years of Engineering experience

OR

Master's degree and 6 years of Engineering experience

OR

Bachelor's degree or and 8 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
  • Master's degree in Engineering, Science or related technological field with 5 years of work experience, with previous experience in the pharmaceutical or biotechnology area.
  • Proven ability to manage and deliver results in a highly fluid, interactive matrixed environment.
  • 10 years of packaging engineering experience in a site and/or corporate engineering environment, with specific specialized expertise in operations and packaging design.
  • 3 years managing a team.
  • 3 years of experience in executing packaging engineering projects (cross functional team managing departmental or functional level projects: approving resources, assigning tasks, presenting milestones, cost/benefit analysis).
  • Strong communication, relationship building, leadership and mentoring skills.
  • AutoCad or similar software application to create, modify and approve engineering drawings.
  • Demonstrated ability to lead teams to successful project results within established time guidelines.
  • Excellent leadership, project management, technical problem solving and communication (written and verbal) skills, and the ability to manage remote people, work in teams and adapt to rapidly changing environment.
  • Demonstrated leadership in a wide range of packaging related technologies with strong fundamental knowledge of primary and secondary packaging systems and processes, manufacturing process equipment and processes, material science, and quality systems.
  • Excellent organizational, project management, technical, problem solving and communication (written and verbal) skills.
  • Demonstrated ability to work with a range of technically and culturally diverse people, influencing them to get the job done, and delivering value-added business results that meet high quality requirements within a tight schedule.


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.

PI115545265

<b>Amgen</b><br/><br/><b>Job ID: </b>R-87798<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><b>Additional Location: </b>US - Puerto Rico - Juncos<br/><br/>The Principal Engineer in Process Development (PD) will report to the Director of Packaging Engineering and Labeling, and will be located in Thousand Oaks, California.<br><br>The successful candidate for this position will lead a team of engineers responsible for the clinical and commercial packaging for drug substance, drug product, primary container closures and final product presentations. The candidate will help create and implement the long-term strategy to ensure that Amgen becomes and remains an industry leader in this area. They will work cross functionally as a Device Technology Lead (DTL) within PD and across Amgen to develop products that create a successful patient experience.<br><br>The Principal Engineer is expected to develop annual goals and strategic direction for the packaging organization to the Final ProductTeamLead(FPTL). The Principal Engineer will identify and drive efficiencies and utilization of the commercialization process, the lifecycle of products, and the overall manufacturing capability of Amgen operations across the global networks.<br><br>Responsibilities Include:<br><ul><li>Design, qualification and implementation of packaging designs</li><li>Pursue packaging technologies that will drive innovation and gain efficiencies in the network</li><li>DTL lead for molecule programs driving packaging strategy and milestone to the PDT</li><li>Consistently deliver results aligned with departmental and program goals.</li><li>Drive continuous improvement in the packaging processes from project initiation through launch as well as life cycle management. In alignment with regulatory and commercial manufacturing requirements.</li><li>Develop and maintain a high performing team of engineers, with advanced degrees and experience in packaging engineering that are professionally and technically competent.</li><li>Be a role model in living the Amgen values and leadership attributes.</li><li>Identify resource requirements to deliver on program portfolio and negotiate resource assignments from leadership.</li><li>Deliver progress reports and presentations ensuring that management is aware of the current status, progress and future needs within Operations.</li><li>Identify and ensure area of responsibility complies with the most current standards and company policies.</li><li>Author regulatory documents in support of molecule applications.</li><li>Provide leadership and guidance to ensure consultants, contract manufacturers, and external business partners comply with business standards and requirements.</li></ul><br><br><b>Basic Qualifications:</b><br><br>Doctorate degree and 2 years of Engineering experience<br><br>OR<br><br>Master's degree and 6 years of Engineering experience<br><br>OR<br><br>Bachelor's degree or and 8 years of Engineering experience<br><br>OR<br><br>Associate's degree and 10 years of Engineering experience<br><br>OR<br><br>High school diploma / GED and 12 years of Engineering experience<br><br><b>Preferred Qualifications</b><br><ul><li>Master's degree in Engineering, Science or related technological field with 5 years of work experience, with previous experience in the pharmaceutical or biotechnology area.</li><li>Proven ability to manage and deliver results in a highly fluid, interactive matrixed environment.</li><li>10 years of packaging engineering experience in a site and/or corporate engineering environment, with specific specialized expertise in operations and packaging design.</li><li>3 years managing a team.</li><li>3 years of experience in executing packaging engineering projects (cross functional team managing departmental or functional level projects: approving resources, assigning tasks, presenting milestones, cost/benefit analysis).</li><li>Strong communication, relationship building, leadership and mentoring skills.</li><li>AutoCad or similar software application to create, modify and approve engineering drawings.</li><li>Demonstrated ability to lead teams to successful project results within established time guidelines.</li><li>Excellent leadership, project management, technical problem solving and communication (written and verbal) skills, and the ability to manage remote people, work in teams and adapt to rapidly changing environment.</li><li>Demonstrated leadership in a wide range of packaging related technologies with strong fundamental knowledge of primary and secondary packaging systems and processes, manufacturing process equipment and processes, material science, and quality systems.</li><li>Excellent organizational, project management, technical, problem solving and communication (written and verbal) skills.</li><li>Demonstrated ability to work with a range of technically and culturally diverse people, influencing them to get the job done, and delivering value-added business results that meet high quality requirements within a tight schedule.</li></ul><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/m6rq8QibDN1BhKlqs4m2Z"> <p>PI115545265</p>

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Posted: 2019-11-16 Expires: 2019-12-17

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Principal Engineer

Amgen
Thousand Oaks, CA 91360

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