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GenentechPosted 1 month ago

Principal Maintenance Specialist, Packaging - CVRM (Holly Springs)

$81,400–$151,200 year

HybridHolly Springs, North Carolina, United States

Full TimeSenior LevelEnterprise

Job Summary

Establish the site's maintenance program for Packaging equipment, including procedures and training, and support FATs during the pre-startup phase. Execute planned preventative maintenance, repairs, and troubleshooting on GMP assets while supporting PLC/automation issues in compliance with cGMP and safety standards. Create continuing education for maintenance staff, manage spare parts identification, and provide inputs to master data in SAP S4/HANA. Perform detailed documentation following Good Documentation Practices and collaborate with Engineering, Quality, and Supply Chain partners. Transition to full-time on-site work with up to 30% travel during the project phase, adhering to controlled environment protocols and aseptic processing principles.

Required Qualifications

  • High School diploma or equivalent
  • 7+ years of related work experience in an industrial / manufacturing setting
  • demonstrated strong mechanical aptitude
  • experience with maintaining high performance pharmaceutical packaging lines
  • ability to organize and solve complex, unique or unprecedented problems
  • familiarity with cGMP's
  • familiarity with Health Authority regulations
  • familiarity with Quality Systems
  • Strong interpersonal skills
  • Strong communication skills (written and verbal)
  • project management skills
  • time management skills
  • Active role which includes lifting up to 35 lbs
  • navigating stairs/ladders/scaffolding
  • transporting equipment to the location of instruments
  • working away from a desk for the majority of working shift
  • Be able to work extensive hours while standing
  • Travel of up to 30% of the time
  • flexible working hours including overtime or on-call
  • work in the clean room environment that requires gowning
  • work near hazardous materials, chemicals, and equipment

Desired Qualifications

  • An A.A., A.S., A.A.S., or Trade School Certificate
  • 5+ years of related work experience
  • Proficient in using AI and other digital tools to solve complex challenges
  • Proficient in Quality Management System(s)
  • Read and Understand P&lDs
  • work from Standard Operating Procedures (SOPs)
  • leverage basic computer skills using word processors, spreadsheets, databases, and email
  • understand controlled, classified environments, aseptic processing principles

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