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Maintenance Specialist

Vacaville
California, United States of America


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The Position

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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Who We Are

A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.

The next step is yours. To apply today, click on the "Apply online" button.

Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.


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