Principal Manufacturing Systems Engineer

4 weeks ago

Thousand Oaks, California, United States Amgen Inc. Full time

Job Summary:

The Principal Manufacturing Systems Engineer will play a key role in ensuring the success of Drug product manufacturing through an extensive understanding and solid background in engineering, configuration, programming, installation, commissioning, maintenance, and troubleshooting of process controls, automation, electrical devices, and field instrumentation technologies.

Key Responsibilities:

  • Design, develop, and deliver innovative solutions enabling the advancement of Amgen Drug Product manufacturing processes.
  • Provide technical leadership for Day-to-day operational shift support for Drug Product manufacturing.
  • Experience in change control, nonconformance, corrective & preventative actions, and Commissioning & Qualification activities.
  • Establishing close working relationships with the Filling Line Original Equipment Manufacturers (OEMs) to better understand the equipment and Automation system design.
  • Leading advanced trouble shooting activities in partnership with the OEMs, Plant Engineering, & Maintenance teams to enhance manufacturing uptime through the highest reliability of filling lines to Manufacturing.
  • Responsible for driving continuous improvement in partnership with plant engineering, maintenance, and OEMs to drive operational efficiencies for the assigned filling line.
  • Responsible to maintain User requirements, Design & Engineering specifications, drawings, Data Integrity assessment, Periodic reviews & Spare parts management.
  • Responsible for collaborating within the Amgen network to learn, implement, and share Continuous improvement opportunities within the Drug Product manufacturing Amgen Global network.
  • Responsible for maintaining and providing support for the operations of the associated plant utilities (WFI, RO, Clean Steam, UPS power distribution, Manufacturing Information System network infrastructure) related to the assigned filling line.
  • Responsible for maintaining Amgen Enterprise Cyber Resiliency compliance through quarterly OS patching of automation systems, servers & workstations.
  • Executive presence & communication of automation topics in the simplest business language at various partner forums in the workplace: Daily plant Work Center Team (WCT) meetings, Weekly plant performance review, F&E WCT, & MCS SLT WCT, Purposeful Presence on the Floor (PPoF)
  • As System Owner, you are accountable for and responsible for providing the necessary support during the internal and external regulatory audits for the assigned filling lines.

Requirements:

  • Doctorate degree and 2 years of Engineering experience
  • Master's degree and 4 years of Engineering experience
  • Bachelor's degree and 6 years of Engineering experience
  • Associate degree and 10 years of Engineering experience
  • High school diploma / GED and 12 years of Engineering experience
  • Master's or Bachelor's Degree in Electrical Engineering or a related field
  • Experienced in the process automation field within the biopharmaceutical industry
  • Experience with Drug Product unit operations such as Lyophilizer, Vial & Syringe Filler, Vial Washer, Capper, Depyrogenation oven & Tray Loader

What We Offer:

  • Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans and bi-annual company-wide shutdowns
  • Flexible work models, including remote work arrangements, where possible

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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