30 days old

Engineering Projects Manager

Amgen
Thousand Oaks, CA 91360
  • Job Code
    117588547
Amgen

Job ID: R-92464
Location: Thousand Oaks, CA, US 91360

The Engineering Projects Manager is responsible for construction and department capital planning of the ATO Manufacturing and Clinical Supply (MCS, previously DSC) organization (includes B6, B7, B23, B30, B20, B31, AMA SUL, ARI PEL, Cell Bank). Business process owner for capital budgeting, governance and prioritization processes

Responsibilities

· Ensure capital projects have visibility during execution to MCS leadership and the manufacturing clients, track critical Implementation date.

· Work with MCS Leadership Team to ensure all capital and expense spending >$5k goes through the proper MCS governance processes (PRTs and CPG).

· Ensure approved capital projects are brought forward for governance approval per the agreed timelines and with the proper up-front planning/information.

· Drive strategic goals of the organization and ensure investments are aligned with strategy

· Identify resource availability or gaps for proposed MCS projects.

· As necessary, engage PM/project lead before project is brought to governance to ensure all proper info is being provided (scope, budget, resources, timeline, etc.). Vet plan and identify any constraints/obstacles that the PM may not be aware of. Mentor/Coach PMs on project execution, delivery and productivity

· Engage plant prioritization teams to efficiently prioritize and develop scope that requires a capital project. Conduct quarterly cross-DSC prioritization to ensure investments are aligned with MCS priorities

· Engage MCS Leadership and plant manager to re-prioritize capital spend as new priorities emerge.

· Partner with LabConnect to track DSC department cap spend and ensure spend is properly invoiced

· Partner with Capital Project Engineering to monitor Construction Capital portfolio and assess associated risks to delivering department capital projects

· Actively participate in the Portfolio and Project Management global network

· Point of contact for Long Range Planned Maintenance Projects across the network; responsible for ensuring proper risk assessments are conducted and reviewed with Plant leadership

Basic Qualifications

Doctorate degree

OR

Master's degree and 3 years of Engineering 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
  • Bachelor's degree in Chemical or Mechanical Engineering
  • 6+ years' of relevant work experience with 5+ years' experience in Biopharmaceutical operations/manufacturing environment
  • Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.) and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation
  • Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems such as cell culture reactors, chromatography, filtration, filling, lyophilization, inspection, device assembly, as well as other equipment needed to support these processes such as autoclaves, clean in place (CIP) systems, washers, clean steam, water for injection, etc.
  • Ability to analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g., Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.)
  • Experience applying engineering principles to the design and implementation of system modifications, introduction of new processes, and execution of capital projects
  • Understanding of the execution process of capital projects in a GMP Biopharmaceutical Production facility including procurement, construction, startup, and validation
  • Understanding of safety requirements working in a GMP Biopharmaceutical Production facility.
  • Independent, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration
  • Team player prepared to work in and embrace a team based culture that relies on collaboration for effective decision-making
  • Strong leadership, technical writing, and communication/presentation skills
  • Work schedule flexibility to support 24/7 operations, requiring occasional after-hours engineering coverage as required from time to time


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.

PI117588547

<b>Amgen</b><br/><br/><b>Job ID: </b>R-92464<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>The Engineering Projects Manager is responsible for construction and department capital planning of the ATO Manufacturing and Clinical Supply (MCS, previously DSC) organization (includes B6, B7, B23, B30, B20, B31, AMA SUL, ARI PEL, Cell Bank). Business process owner for capital budgeting, governance and prioritization processes <br><br><b>Responsibilities</b><br><br> Ensure capital projects have visibility during execution to MCS leadership and the manufacturing clients, track critical Implementation date. <br><br> Work with MCS Leadership Team to ensure all capital and expense spending >$5k goes through the proper MCS governance processes (PRTs and CPG). <br><br> Ensure approved capital projects are brought forward for governance approval per the agreed timelines and with the proper up-front planning/information. <br><br> Drive strategic goals of the organization and ensure investments are aligned with strategy <br><br> Identify resource availability or gaps for proposed MCS projects. <br><br> As necessary, engage PM/project lead before project is brought to governance to ensure all proper info is being provided (scope, budget, resources, timeline, etc.). Vet plan and identify any constraints/obstacles that the PM may not be aware of. Mentor/Coach PMs on project execution, delivery and productivity <br><br> Engage plant prioritization teams to efficiently prioritize and develop scope that requires a capital project. Conduct quarterly cross-DSC prioritization to ensure investments are aligned with MCS priorities <br><br> Engage MCS Leadership and plant manager to re-prioritize capital spend as new priorities emerge. <br><br> Partner with LabConnect to track DSC department cap spend and ensure spend is properly invoiced <br><br> Partner with Capital Project Engineering to monitor Construction Capital portfolio and assess associated risks to delivering department capital projects <br><br> Actively participate in the Portfolio and Project Management global network <br><br> Point of contact for Long Range Planned Maintenance Projects across the network; responsible for ensuring proper risk assessments are conducted and reviewed with Plant leadership <br><br><b>Basic Qualifications</b><br><br>Doctorate degree<br><br>OR<br><br>Master's degree and 3 years of Engineering 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><ul><li>Bachelor's degree in Chemical or Mechanical Engineering</li><li>6+ years' of relevant work experience with 5+ years' experience in Biopharmaceutical operations/manufacturing environment</li><li>Experience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.) and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation </li><li>Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems such as cell culture reactors, chromatography, filtration, filling, lyophilization, inspection, device assembly, as well as other equipment needed to support these processes such as autoclaves, clean in place (CIP) systems, washers, clean steam, water for injection, etc.</li><li>Ability to analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g., Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.)</li><li>Experience applying engineering principles to the design and implementation of system modifications, introduction of new processes, and execution of capital projects</li><li>Understanding of the execution process of capital projects in a GMP Biopharmaceutical Production facility including procurement, construction, startup, and validation</li><li>Understanding of safety requirements working in a GMP Biopharmaceutical Production facility.</li><li>Independent, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration</li><li>Team player prepared to work in and embrace a team based culture that relies on collaboration for effective decision-making</li><li>Strong leadership, technical writing, and communication/presentation skills</li><li>Work schedule flexibility to support 24/7 operations, requiring occasional after-hours engineering coverage as required from time to time</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/oznbnruqGaezt6d4ulX6R"> <p>PI117588547</p>

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Posted: 2020-01-30 Expires: 2020-03-01

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Engineering Projects Manager

Amgen
Thousand Oaks, CA 91360

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