26 days old

Specialist Clinical Supply Chain - Werum MES

Amgen
Thousand Oaks, CA 91360
  • Job Code
    118752728
Amgen

Job ID: R-94947
Location: Thousand Oaks, CA, US 91360

The Specialist role reports to the Thousand Oaks site MES business lead within our Manufacturing & Clinical Supply (MCS) organization. The key responsibilities of this role include acting as a subject matter specialist for the Manufacturing Execution System (MES PAS-X) and facilitating expansion of system functionalities to meet the digital transformation goals of our organization.

Position responsibilities include:

  • Monitoring the MES interface, troubleshooting and triage of technical incidents with Operations, IS and QA
  • Leading projects in support of MCS's digital road-map. This includes MES system expansion, MES Equipment Management (EQM), Level 2 integration and various Product Lifecycle Management (PLM) initiatives
  • Providing detailed SME input/guidance on Electronic Batch Record(EBR) configuration, maintenance and testing
  • Developing and maintaining of both training materials and training data in lower environments.
  • Performing instructor training for MES
  • Serving as a primary tester for system upgrades and patches including data preparation and defect resolution
  • Developing and maintaining system performance metrics
  • Representing the Thousand Oaks instance of MES internally within Amgen's Global Network and externally with vendor


Basic Qualifications :

Doctorate degree

Or

Master's degree and 3 years of Werum MES and Operations experience

Or

Bachelor's degree and 4 years of Werum MES and Operations experience

Or

Associate's degree and 10 years of Werum MES and Operations experience

Or

High school diploma / GED and 12 years of Werum MES and Operations experience

Preferred Qualifications :

  • Significant experience with Werum PAS|X in the areas of MBR configuration/Editing, Order Network processing, Equipment Management, Finite Scheduling and Level 2 integration
  • Experience with data acquisition tools, such as Spotfire
  • Experience with IS management tools, such as ISM
  • Experience in Drug Substance, Drug Product or Packaging Operations
  • Experience with regulatory audits.


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.

PI118752728

<b>Amgen</b><br/><br/><b>Job ID: </b>R-94947<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>The Specialist role reports to the Thousand Oaks site MES business lead within our Manufacturing & Clinical Supply (MCS) organization. The key responsibilities of this role include acting as a subject matter specialist for the Manufacturing Execution System (MES PAS-X) and facilitating expansion of system functionalities to meet the digital transformation goals of our organization.<br><br><b>Position responsibilities include:</b><br><br><ul><li>Monitoring the MES interface, troubleshooting and triage of technical incidents with Operations, IS and QA</li><li>Leading projects in support of MCS's digital road-map. This includes MES system expansion, MES Equipment Management (EQM), Level 2 integration and various Product Lifecycle Management (PLM) initiatives</li><li>Providing detailed SME input/guidance on Electronic Batch Record(EBR) configuration, maintenance and testing</li><li>Developing and maintaining of both training materials and training data in lower environments.</li><li>Performing instructor training for MES</li><li>Serving as a primary tester for system upgrades and patches including data preparation and defect resolution</li><li>Developing and maintaining system performance metrics</li><li>Representing the Thousand Oaks instance of MES internally within Amgen's Global Network and externally with vendor</li></ul><br><br><b><b>Basic Qualifications :</b></b><br><br>Doctorate degree<br><br><b>Or</b><br><br>Master's degree and 3 years of Werum MES and Operations experience<br><br><b>Or</b><br><br>Bachelor's degree and 4 years of Werum MES and Operations experience<br><br><b>Or</b><br><br>Associate's degree and 10 years of Werum MES and Operations experience<br><br><b>Or</b><br><br>High school diploma / GED and 12 years of Werum MES and Operations experience<br><br><b><b>Preferred Qualifications :</b></b><br><br><ul><li>Significant experience with Werum PAS|X in the areas of MBR configuration/Editing, Order Network processing, Equipment Management, Finite Scheduling and Level 2 integration</li><li>Experience with data acquisition tools, such as Spotfire</li><li>Experience with IS management tools, such as ISM</li><li>Experience in Drug Substance, Drug Product or Packaging Operations</li><li>Experience with regulatory audits.</li></ul><br><br><b><b>Join Us</b></b><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>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/2VrVDbhWKM52IZVPFDBKj"> <p>PI118752728</p>

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Posted: 2020-03-05 Expires: 2020-04-05

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Specialist Clinical Supply Chain - Werum MES

Amgen
Thousand Oaks, CA 91360

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