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Equipment Engineer
Brand: Irvine Pharmaceutical Services
Req#: 164629
Updated: 01/28/2014
Job Type: Full Time
Location: Irvine, CA
Category: Operations
Salary: Salary
Benefits: Full Benefits
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Job Description

The Equipment Engineer is primarily responsible for providing engineering support for manufacturing, validation, and quality departments. These duties include performing engineering runs to develop cycle recipes and parameters for filling equipment, steam sterilizers, dry heat ovens, and the freeze dryer; supporting maintenance in troubleshooting and resolving equipment problems; and reviewing equipment for process optimization and improvement. Also responsible for supporting Equipment Change Control (ECC) and Work Order (WO) processes, including writing ECCs and WOs, and writing impact assessments for them.

Secondary responsibilities include reviewing, writing, and updating maintenance and calibration procedures for new and existing equipment; providing training to operators and maintenance technicians on new and existing equipment; and writing and reviewing User Requirement Specifications (URS) for new equipment.

  • BS in Engineering and 4+ years experience working at a pharmaceutical manufacturing facility. Or equivalent job experience with a technical degree and 9+ years of experience working at a pharmaceutical manufacturing facility.
  • Calibration and maintenance of components specifically related to Freeze Dryers (Lyophilization), Pure Steam Generators, Steam Sterilizers, Vial Washers, Liquid Fill Machines, Water For Injection Distillation, Reverse Osmosis/De-Ionized Water generation and distribution systems.
  • Must be able to pass Aseptic Gowning Certification.

Additional preferred experience:

  • Experience setting up, maintaining, calibrating, and operating an aseptic filling machine.
  • HVAC and Chiller experience.
  • Automation experience with Allen Bradley and/or Siemens control systems.
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