16 days old

Sr Engineer

Amgen
Thousand Oaks, CA 91360
  • Job Code
    115671294
  • Jobs Rated
    8th
Amgen

Job ID: R-82291
Location: Thousand Oaks, CA, US 91360

Amgen (NASDAQ:AMGN), 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. With a deep and broad pipeline of potential new medicines, we continue to advance science to serve patients.

The Senior Engineer is responsible for engineering activities required for development / qualification / validation and transfer of GMP physical test methods and container closure integrity test methods for combination products, devices, primary container, and secondary packaging components, as required. This individual shall have the ability to work on multiple projects at one time that may involve either new or changed product, process, tooling or equipment introduction to improve product quality and reliability.

RESPONSIBILITIES:

  • Assure transfer of new combination product test methods or container closure integrity methods to QC or manufacturing, by developing six sigma processes and compiling all required documentation.
  • Implement projects per FPT (Final Product Technologies) and company procedures to ensure projects are completed on schedule and within established budget.
  • Provide expert support in the design or redesign of tools and/or equipment required for manufacturing processes.
  • Provide expert support for investigations as well as new processes development required to improve manufacturing operations. Improvements may be required for a variety of reasons (i.e. quality, reliability, new product introduction, cost saving).
  • Coordinate gauge and equipment development and delivery with selected contractors.
  • Ensure that qualification parameters are met for product assembly and performance requirements.
  • Support development of cost estimates for new processes, gauges and equipment development used in generation of capital request documentation.
  • Generate procedures necessary to support department and new product equipment.
  • Provide expert training to individuals in the operation and maintenance of processes, gauges and equipment introduced to the manufacturing department (i.e. production operator, mechanics, process engineers).
  • Participate in and assume responsibilities of team functions as assigned (i.e. Product Improvement Teams). Supervise work of support staff during development and manufacture of system.
  • Excellent communication (written and verbal) and organizational skills
  • Develops and maintains integrated timelines capturing appropriate cross functional details and deliverables which are aligned with the functional and project deliverables
  • Networks with manufacturing, quality and regulatory organizations both internal and external to Amgen
  • Facilitates robust horizontal communication to ensure all functions are aware of changes in deliverablesand impacts to risk.
  • Proactively identifies issues and/or risks and develops mitigation options to resolve or escalate efficiently
  • Integrates partner/vendor timelines with Amgen timelines as appropriate



The position will require approximately 10% travel to international locations assisting our development partners during implementation of mechanical engineering methods into their processes.

Basic Qualifications:

Doctorate degree

OR

Master's degree and 3 years ofengineering 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:

Masters in Mechanical, Biomedical Engineering or Materials Science

6 + years of experience in the Pharmaceutical/Biotechnology industry or Medical Device industry

Excellent written and verbal communication skills together with demonstrated ability to work in a team environment

Proven track record of project management and leading cross-functional projects

Ability to coach junior engineers

Strong team work, excellent interpersonal and communication skills

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.

PI115671294

<b>Amgen</b><br/><br/><b>Job ID: </b>R-82291<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>Amgen (NASDAQ:AMGN), 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. With a deep and broad pipeline of potential new medicines, we continue to advance science to serve patients.<br><br>The Senior Engineer is responsible for engineering activities required for development / qualification / validation and transfer of GMP physical test methods and container closure integrity test methods for combination products, devices, primary container, and secondary packaging components, as required. This individual shall have the ability to work on multiple projects at one time that may involve either new or changed product, process, tooling or equipment introduction to improve product quality and reliability.<br><br>RESPONSIBILITIES:<br><br><ul><li>Assure transfer of new combination product test methods or container closure integrity methods to QC or manufacturing, by developing six sigma processes and compiling all required documentation.</li><li>Implement projects per FPT (Final Product Technologies) and company procedures to ensure projects are completed on schedule and within established budget.</li><li>Provide expert support in the design or redesign of tools and/or equipment required for manufacturing processes.</li><li>Provide expert support for investigations as well as new processes development required to improve manufacturing operations. Improvements may be required for a variety of reasons (i.e. quality, reliability, new product introduction, cost saving).</li><li>Coordinate gauge and equipment development and delivery with selected contractors.</li><li>Ensure that qualification parameters are met for product assembly and performance requirements.</li><li>Support development of cost estimates for new processes, gauges and equipment development used in generation of capital request documentation.</li><li>Generate procedures necessary to support department and new product equipment.</li><li>Provide expert training to individuals in the operation and maintenance of processes, gauges and equipment introduced to the manufacturing department (i.e. production operator, mechanics, process engineers).</li><li>Participate in and assume responsibilities of team functions as assigned (i.e. Product Improvement Teams). Supervise work of support staff during development and manufacture of system.</li><li>Excellent communication (written and verbal) and organizational skills</li><li>Develops and maintains integrated timelines capturing appropriate cross functional details and deliverables which are aligned with the functional and project deliverables</li><li>Networks with manufacturing, quality and regulatory organizations both internal and external to Amgen</li><li>Facilitates robust horizontal communication to ensure all functions are aware of changes in deliverablesand impacts to risk.</li><li>Proactively identifies issues and/or risks and develops mitigation options to resolve or escalate efficiently</li><li>Integrates partner/vendor timelines with Amgen timelines as appropriate</li></ul><br><br><br>The position will require approximately 10% travel to international locations assisting our development partners during implementation of mechanical engineering methods into their processes.<br><br><b>Basic Qualifications:</b><br><br>Doctorate degree<br><br>OR<br><br>Master's degree and 3 years ofengineering experience<br><br>OR<br><br>Bachelor's degree and 5 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><br>Masters in Mechanical, Biomedical Engineering or Materials Science<br><br>6 + years of experience in the Pharmaceutical/Biotechnology industry or Medical Device industry<br><br>Excellent written and verbal communication skills together with demonstrated ability to work in a team environment<br><br>Proven track record of project management and leading cross-functional projects<br><br>Ability to coach junior engineers<br><br>Strong team work, excellent interpersonal and communication skills<br><br>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.<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>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>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/7eRDA4SYXOpqiZ1NF7Y5y"> <p>PI115671294</p>

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Posted: 2019-11-21 Expires: 2019-12-22

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Sr Engineer

Amgen
Thousand Oaks, CA 91360

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Software Engineer
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