24 days old

Senior Associate Manufacturing

Amgen
West Greenwich, RI 02817
  • Job Code
    118800469
Amgen

Job ID: R-95414
Location: West Greenwich, RI, US 02817

C Shift - Rotating Nights (7pm - 7am)

Under minimal supervision, the Senior Associate Manufacturing will support operations in the Manufacturing Services on Night Shift. The Senior Associate Manufacturing will own, monitor and troubleshoot critical processes and regularly draft and revise documents such as Manufacturing Procedures, SOPs, and technical reports such as deviations.

The Senior Associate Manufacturing will participate in cross-functional teams. Senior Associate Manufacturing will also have the responsibility of owning at a minimum: Manufacturing Services Unit operations, SOPs, CAPA's, Change controls and Deviations. In addition, the Senior Associate Manufacturing Services will initially identify, recommend, and implement improvements related to routine floor operations.

Basic Qualifications:
  • Master's Degree
  • OR
  • Bachelor's degree and 2 years of Manufacturing or Operations experience
  • OR
  • Associate's degree and 6 years of Manufacturing or Operations experience
  • OR
  • High School diploma/GED and 8 years of Manufacturing or Operations experience


Preferred Qualifications:
  • Knowledge of Washers and Autoclaves
  • Prior experience with process equipment, computers, and intermediate mathematical skills.
  • CFR and Regulatory knowledge
  • Experience and Knowledge Weigh Dispensing
  • Strong understanding of BDS equipment and CIP and SIP processes
  • Ability to interpret and apply GMP knowledge
  • Understanding of analytical methods for the manufacturing area
  • Ability to demonstrate technical writing capability with Trackwise access
  • Independently collaborate with outside resources
  • Ability to understand, apply and evaluate basic chemistry, biology and physical principles
  • Experience with Delta V, RDs, and the PI system
  • Manufacturing Services Experience (troubleshooting critical processes)
  • Purification, Cell Culture or Solutions Prep. Experience (troubleshooting critical processes)
  • Hands on experience facilitating problem solving and root cause investigations in a biotechnology environment (Deviation / Nonconformance investigation writing experience)
  • Regulatory knowledge and experience with regulatory audits
  • Ability to interpret and apply GMP knowledge
  • Mechanical expertise
  • Knowledge computers, with LIMS access
  • Understanding of analytical methods for manufacturing area
  • Ability to demonstrate technical writing capability
  • Basic troubleshooting skills on Manufacturing equipment including single use equipment
  • Experience with Delta V/MES/SAP/LIMS with access


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 demonstrates 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.

PI118800469

<b>Amgen</b><br/><br/><b>Job ID: </b>R-95414<br/><b>Location: </b>West Greenwich, RI, US 02817<br/><br/>C Shift - Rotating Nights (7pm - 7am)<br><br>Under minimal supervision, the Senior Associate Manufacturing will support operations in the Manufacturing Services on Night Shift. The Senior Associate Manufacturing will own, monitor and troubleshoot critical processes and regularly draft and revise documents such as Manufacturing Procedures, SOPs, and technical reports such as deviations.<br><br>The Senior Associate Manufacturing will participate in cross-functional teams. Senior Associate Manufacturing will also have the responsibility of owning at a minimum: Manufacturing Services Unit operations, SOPs, CAPA's, Change controls and Deviations. In addition, the Senior Associate Manufacturing Services will initially identify, recommend, and implement improvements related to routine floor operations.<br><br><b>Basic Qualification</b>s:<br><ul><li>Master's Degree</li><li>OR</li><li>Bachelor's degree and 2 years of Manufacturing or Operations experience</li><li>OR</li><li>Associate's degree and 6 years of Manufacturing or Operations experience</li><li>OR</li><li>High School diploma/GED and 8 years of Manufacturing or Operations experience</li></ul><br><br><b>Preferred Qualifications: </b><br><ul><li>Knowledge of Washers and Autoclaves</li><li>Prior experience with process equipment, computers, and intermediate mathematical skills.</li><li>CFR and Regulatory knowledge</li><li>Experience and Knowledge Weigh Dispensing</li><li>Strong understanding of BDS equipment and CIP and SIP processes</li><li>Ability to interpret and apply GMP knowledge</li><li>Understanding of analytical methods for the manufacturing area</li><li>Ability to demonstrate technical writing capability with Trackwise access</li><li>Independently collaborate with outside resources</li><li>Ability to understand, apply and evaluate basic chemistry, biology and physical principles</li><li>Experience with Delta V, RDs, and the PI system</li><li>Manufacturing Services Experience (troubleshooting critical processes)</li><li>Purification, Cell Culture or Solutions Prep. Experience (troubleshooting critical processes)</li><li>Hands on experience facilitating problem solving and root cause investigations in a biotechnology environment (Deviation / Nonconformance investigation writing experience)</li><li>Regulatory knowledge and experience with regulatory audits</li><li>Ability to interpret and apply GMP knowledge</li><li>Mechanical expertise</li><li>Knowledge computers, with LIMS access</li><li>Understanding of analytical methods for manufacturing area</li><li>Ability to demonstrate technical writing capability</li><li>Basic troubleshooting skills on Manufacturing equipment including single use equipment</li><li>Experience with Delta V/MES/SAP/LIMS with access</li></ul><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 demonstrates 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/Z4aRG4S1yz6EcxqmIbXn4"> <p>PI118800469</p>

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Posted: 2020-03-06 Expires: 2020-04-06

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Senior Associate Manufacturing

Amgen
West Greenwich, RI 02817

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