Lead Tech, Maintenance

Role: Lead Technical Engineer supporting biopharmaceutical manufacturing start-up in Durham, NC, focusing on equipment installation, operation, maintenance, and troubleshooting across biotech processes including culture growth, harvest, lyophilization, and inspection. Responsibilities: maintain process and support equipment (e.g., bioreactors, washers, autoclaves, filtration skids), develop SOPs and preventive maintenance plans, support validation and root cause investigations, and ensure safety and compliance with GMP standards. Collaborate across operations, quality, automation, and engineering teams; support calibration, automation, and change control activities; manage spare parts inventory and SAP transactions. Requirements: BSc in Engineering/Science or 2+ years in production/maintenance, or 6+ years plant maintenance experience with technical skills in instrumentation, electrical, HVAC, or mechanical systems. Must be familiar with GMP and cGMP environments, and proficient in CMMS, PLCs, and Microsoft Office. Physical ability to lift 50 lbs, work in cleanroom attire, and perform on-call weekend shifts. Preferred: SAP experience, sterile pharmaceutical environment exposure, biopharma equipment troubleshooting, reading P&IDs and electrical drawings, and knowledge of Allen Bradley PLCs and Siemens BAS. Work setup: on-site in Durham, with no travel required.