27 days old

Engineer

Amgen
Thousand Oaks, CA 91360
  • Job Code
    116523093
Amgen

Job ID: R-90007
Location: Thousand Oaks, CA, US 91360

This engineering position supports manufacturing activities associated with cGMP equipment and facilities at Amgen Thousand Oaks (ATO). The engineer will lead activities in alignment with Amgen's Commissioning and Qualification Process (CQP) to ensure that new GMP equipment is installed and maintained in a validated state. The engineer works in partnership with the maintenance, Project Management, Engineering Technical Lead, and manufacturing to develop and oversee the operation and reliability of equipment. The engineer must work closely with Quality Assurance (QA) for GMP compliance. In addition, the engineer will support periodic review of manufacturing systems to ensure that they remain in a validated state. The engineer will support the projects in defining strategies for quality systems verification and will work with the process development / validation team to develop and document appropriate practices for characterization.

The Engineer role will provide direct engineering technical support as follows:
  • Be individually accountable for the verification deliverables on key capital projects
  • Assist in the identification of critical quality parameters and process attributes for new equipment or facility modifications.
  • Assist in development and review of User Requirements Specifications (URS).
  • Suggest design modifications to address risks and design in quality and safety.
  • Develop the commissioning strategy based on the URS and Quality Risk Assessment for Automation and Equipment Systems (QRAES) to validate equipment design while minimizing project cost and schedule impact (risk-based approach).
  • Oversee development of validation protocols in line with CQP, Automation Systems Delivery SOPs, and cGMP standards.
  • Recommend, evaluate, and manage performance of contract resources
  • Provide oversight for verification deliverables developed by outsourced/contract verification staff.
  • Act as a liaison between Engineering and Quality Assurance during project planning, execution, and closeout
  • Ensure that validation protocols are executed and documented in accordance with cGMP good documentation and safety compliant practices.
  • Ensure safety during commissioning, validation, maintenance and manufacturing activities
  • Review and approve the commissioning report and ensure that all verification exceptions have been adequately addressed
  • Support Manufacturing and QA with Performance Qualification (PQ) activities if applicable.
  • Conduct and document periodic equipment validation reviews

Related Activities:
  • Participate or lead, when required, multidisciplinary site teams, e.g. Cross Functional Team, Root Cause Analysis lead.
  • Support Lean Transformation and Excellence in Operations process improvement by leading, supporting, and documenting improvement opportunities to reduce cost, improve safety/quality, or improve speed.
  • Provide ad hoc technical support and guidance for manufacturing and maintenance
  • Provide coaching and guidance to project teams and engineers on the CQP process and risk-based approaches to commissioning and verification
  • Defend the equipment-specific calibration, maintenance, & validation as required during regulatory inspections
  • Participate in internal audits and assess in conjunction with QA.
  • Assist in developing and maintaining metrics


Basic Qualifications

Master's degree

OR
Bachelor's degree & 2 years of engineering and/or manufacturing experience

OR

Associate's degree & 6 years of engineering and/or manufacturing experience

OR

High school diploma / GED & 8 years of engineering and/or manufacturing experience

Preferred Qualifications
  • Bachelor's degree in engineering or another science-related field
  • 7+ years of relevant work experience with 5+ years' experience in operations/manufacturing environment
  • Direct experience with regulated environments (FDA, OSHA, EPA, etc.)
  • Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, clean utilities, facilities, instruments and equipment
  • Experience implementing risk-based verification on major GMP process equipment / automation projects, including validation protocol development and execution
  • Experience with combination product / medical device quality systems verification
  • Process equipment knowledge - cell culture, fermentation, purification, filling, and packaging
  • Process automation knowledge - understanding of automation infrastructure, current technologies, and automation project execution / verification.
    • Knowledge of Delta V, Rockwell, and Plant Information Systems is a plus
  • Demonstrated strong communication and technical writing skills
  • Strengths in facilitation and collaboration / networking
  • Experience in developing SOPs and delivering training
  • Individual must be a team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making
  • Proven track record of applying process improvement methodologies to mature and improve business processes (e.g. PDCA, LEAN, Six Sigma, and fundamental understanding of statistics, etc.)
  • Demonstrated skills in the following areas:
    • Problem solving and applied engineering.
    • Basic technical report writing.
    • Verbal communication.
  • Demonstrated Skills in the following areas:
    • Basic technical presentations.
    • Personal Organization.
    • Dealing with and managing change.
    • Technical (Equipment Specific).
    • Analytical Problem Solving.
    • Computer Literacy (Maximo, Track wise, E-Builder, PCS, BMS and QEMS).
  • Specialized equipment/process expertise.
  • Ability to handle multiple projects at the same time.
  • Demonstrated Skills in the following areas:
    • Schedule development
    • Facilitation
    • Collaboration
    • Basic project management
    • Completion and follow-up
  • Problem solving skills requiring the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach.
  • Demonstrated Skills in the following areas:
    • Negotiation, persuasion and facilitation Collaboration
    • Project Cost development
    • Conflict Resolution
    • Leadership and team building
    • Schedule and resources loading development
    • Customer service in a technical setting
  • Management of contractors and vendors.
  • Flexibility to work off-hours.


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.

PI116523093

<b>Amgen</b><br/><br/><b>Job ID: </b>R-90007<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>This engineering position supports manufacturing activities associated with cGMP equipment and facilities at Amgen Thousand Oaks (ATO). The engineer will lead activities in alignment with Amgen's Commissioning and Qualification Process (CQP) to ensure that new GMP equipment is installed and maintained in a validated state. The engineer works in partnership with the maintenance, Project Management, Engineering Technical Lead, and manufacturing to develop and oversee the operation and reliability of equipment. The engineer must work closely with Quality Assurance (QA) for GMP compliance. In addition, the engineer will support periodic review of manufacturing systems to ensure that they remain in a validated state. The engineer will support the projects in defining strategies for quality systems verification and will work with the process development / validation team to develop and document appropriate practices for characterization.<br><br>The Engineer role will provide direct engineering technical support as follows:<br><ul><li>Be individually accountable for the verification deliverables on key capital projects</li><li>Assist in the identification of critical quality parameters and process attributes for new equipment or facility modifications.</li><li>Assist in development and review of User Requirements Specifications (URS).</li><li>Suggest design modifications to address risks and design in quality and safety.</li><li>Develop the commissioning strategy based on the URS and Quality Risk Assessment for Automation and Equipment Systems (QRAES) to validate equipment design while minimizing project cost and schedule impact (risk-based approach).</li><li>Oversee development of validation protocols in line with CQP, Automation Systems Delivery SOPs, and cGMP standards.</li><li>Recommend, evaluate, and manage performance of contract resources</li><li>Provide oversight for verification deliverables developed by outsourced/contract verification staff.</li><li>Act as a liaison between Engineering and Quality Assurance during project planning, execution, and closeout</li><li>Ensure that validation protocols are executed and documented in accordance with cGMP good documentation and safety compliant practices.</li><li>Ensure safety during commissioning, validation, maintenance and manufacturing activities</li><li>Review and approve the commissioning report and ensure that all verification exceptions have been adequately addressed</li><li>Support Manufacturing and QA with Performance Qualification (PQ) activities if applicable.</li><li>Conduct and document periodic equipment validation reviews</li></ul><br>Related Activities:<br><ul><li>Participate or lead, when required, multidisciplinary site teams, e.g. Cross Functional Team, Root Cause Analysis lead.</li><li>Support Lean Transformation and Excellence in Operations process improvement by leading, supporting, and documenting improvement opportunities to reduce cost, improve safety/quality, or improve speed.</li><li>Provide ad hoc technical support and guidance for manufacturing and maintenance</li><li>Provide coaching and guidance to project teams and engineers on the CQP process and risk-based approaches to commissioning and verification</li><li>Defend the equipment-specific calibration, maintenance, & validation as required during regulatory inspections</li><li>Participate in internal audits and assess in conjunction with QA.</li><li>Assist in developing and maintaining metrics</li></ul><br><br><b><b>Basic Qualifications</b></b><br><br>Master's degree<br><br>OR<br>Bachelor's degree & 2 years of engineering and/or manufacturing experience<br><br>OR<br><br>Associate's degree & 6 years of engineering and/or manufacturing experience<br><br>OR<br><br>High school diploma / GED & 8 years of engineering and/or manufacturing experience<br><br><b><b>Preferred Qualifications </b></b><br><ul><li>Bachelor's degree in engineering or another science-related field</li><li>7+ years of relevant work experience with 5+ years' experience in operations/manufacturing environment</li><li>Direct experience with regulated environments (FDA, OSHA, EPA, etc.)</li><li>Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, clean utilities, facilities, instruments and equipment</li><li>Experience implementing risk-based verification on major GMP process equipment / automation projects, including validation protocol development and execution</li><li>Experience with combination product / medical device quality systems verification</li><li>Process equipment knowledge - cell culture, fermentation, purification, filling, and packaging</li><li>Process automation knowledge - understanding of automation infrastructure, current technologies, and automation project execution / verification.<ul><li>Knowledge of Delta V, Rockwell, and Plant Information Systems is a plus</li></ul></li><li>Demonstrated strong communication and technical writing skills</li><li>Strengths in facilitation and collaboration / networking</li><li>Experience in developing SOPs and delivering training</li><li>Individual must be a team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making</li><li>Proven track record of applying process improvement methodologies to mature and improve business processes (e.g. PDCA, LEAN, Six Sigma, and fundamental understanding of statistics, etc.)</li><li>Demonstrated skills in the following areas:<ul><li>Problem solving and applied engineering.</li><li>Basic technical report writing.</li><li>Verbal communication.</li></ul></li></ul><ul><li>Demonstrated Skills in the following areas:<ul><li>Basic technical presentations.</li><li>Personal Organization.</li><li>Dealing with and managing change.</li><li>Technical (Equipment Specific).</li><li>Analytical Problem Solving.</li><li>Computer Literacy (Maximo, Track wise, E-Builder, PCS, BMS and QEMS).</li></ul></li><li>Specialized equipment/process expertise.</li><li>Ability to handle multiple projects at the same time.</li><li>Demonstrated Skills in the following areas:<ul><li>Schedule development</li><li>Facilitation</li><li>Collaboration</li><li>Basic project management</li><li>Completion and follow-up</li></ul></li><li>Problem solving skills requiring the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach.</li><li>Demonstrated Skills in the following areas:<ul><li>Negotiation, persuasion and facilitation Collaboration</li><li>Project Cost development</li><li>Conflict Resolution</li><li>Leadership and team building</li><li>Schedule and resources loading development</li><li>Customer service in a technical setting</li></ul></li><li>Management of contractors and vendors.</li><li>Flexibility to work off-hours.</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/LYWbV7T1WGk4sB74iq27g"> <p>PI116523093</p>
Posted: 2019-12-21 Expires: 2020-01-21

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Engineer

Amgen
Thousand Oaks, CA 91360

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