5 days old

Maintenance Specialist

Genentech
Vacaville, CA 95688

Technical:

  • Develop, review, and approve preventative maintenance and cleaning procedures for process equipment and systems.
  • Collaborate with maintenance staff and engineering colleagues in the continuous improvement of engineering technical infrastructure required to support the process related systems, including best maintenance practices, specifications, and procedures.
  • Conduct engineering technical assessments as part of discrepancy evaluations, CAPAs, and quality investigations.
  • Participate in engineering design, implementation, commissioning and qualification of process/utility equipment/systems.
  • Collaborate with site and Corporate Engineering on facility modifications, process expansions and new installations.
  • Interact and communicate with Manufacturing, Quality, Technology, and Engineering to ensure satisfactory performance of process equipment/systems.
  • Review and approve Work Orders, Change Records, and Maintenance related Documents.
  • Provide engineering technical expertise and guidance to other technical staff members.
  • Supporting Instrument failures through Calibrated Asset Performance Evaluation*
  • Supporting standard failures though Reverse Trace Reports*
  • Primary owner of the site HEPA Program
  • Primary owner of the site Refrigerant Program
  • Primary owner of the site Calibration Program
  • Provide flexible and on-call support of 24x7 operations, as needed.

Job Requirements

Education:

  • BA/BS or equivalent in a scientific or engineering discipline with a minimum of 6 years of experience in Utilities, Maintenance and/or Instrumentation, or 12 years of equivalent experience in a related industry.

Experience (may vary depending on site size/scope)

  • Comprehensive knowledge of safety principles and quality systems in a highly regulated manufacturing environment
  • 3 to 5 years working in a cGMP, manufacturing environment ideally providing maintenance support on Drug Product or Drug Substance equipment

Knowledge/Skills/Competencies

  • Strong proficiency in maintenance principles and techniques, and demonstrated ability in successfully applying that knowledge.
  • Strong technical leadership and able to work independently or as part of a multidisciplinary team.
  • Experience in engineering documentation such as P&IDs and Design Specifications related to process equipment and systems.
  • Effective communication and interpersonal skills with Maintenance, Technical, Operations, Quality, and senior management.

Work Environment/Physical Demands/Safety Considerations

  • Must be able to work weekends, off shifts, and overtime as required to support a 24x7 manufacturing operation
  • Must be able to lift 50 lbs, push/pull >100 pounds of force
  • Must be able to stand or sit for extended periods of time
  • Must be able to climb stairs and walk for extended periods of time
  • Must be able to perform computer work with heavy mouse use
  • Must be able to meet gowning requirements such as safety glasses, full gowns, steel toes boots, etc. No makeup or jewelry of any kind can be worn inside the manufacturing plant.

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Posted: 2020-05-20 Expires: 2020-06-19

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Maintenance Specialist

Genentech
Vacaville, CA 95688

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