Process Maintenance Specialist

3 weeks ago


Raleigh, United States Tek Support Full time

Responsibilities:

  • Perform preventive maintenance and repairs on process equipment (bioreactors, ultrafiltration skids, autoclaves, isolators, fillers, etc.)
  • Troubleshoot and resolve equipment malfunctions
  • Support installation, commissioning, and validation of new equipment
  • Develop and revise SOPs for process maintenance activities
  • Maintain accurate documentation in compliance with GMP standards
  • Assist in passivation, gasket replacement, and diaphragm seal changes for clean steam generators and bioreactors
  • Adhere to safety requirements and report hazards to management or EHS
  • Provide on-call support for emergency work orders as needed


Key Requirements:

Must-Have Experience:

  • Maintenance of isolators, autoclaves, buffer prep, skids, and bioreactors in GMP environments
  • Preventative maintenance and equipment repair
  • Experience with utilities and process maintenance in GMP settings

Preferred Experience:

  • Gowning in Class C environments (highly preferred for role extension)
  • Commissioning and validation experience
  • FAT experience for facility expansions


Basic Qualifications:

  • High School Diploma/GED
  • 4+ years of maintenance experience in GMP pharmaceutical or similar manufacturing settings
  • Experience with Computerized Maintenance Management Systems (CMMS)
  • Knowledge of mechanical, electrical, and control systems


Preferred Qualifications:

  • Associate degree in Mechanical, Electrical, or Chemical Engineering
  • 5+ years of maintenance experience in GMP environments
  • Relevant certifications (e.g., Certified Maintenance & Reliability Professional)



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