Instrumentation & Equipment Specialist II (3rd Shift Sunday - Wednesday, 10:00pm - 8:30am)
Core
Maintenance, calibration, and repair of equipment, utilities, and systems supporting cGMP Manufacturing, Laboratories, and Warehouse operations.
Role type
Senior IC instrumentation and equipment specialist (3rd shift)
Builds
cGMP-compliant manufacturing and laboratory environments
Domain
Biopharmaceutical cell therapy manufacturing
Deliverable
infrastructure
Required skills
Preventative and corrective maintenance, calibration/metrology, PLC troubleshooting, HVAC systems, electrical systems, mechanical systems, BMS/QEMS monitoring, P&ID reading, root cause analysis, Computerized Maintenance Management Software (Blue Mountain), Building Management Systems (Siemens Desigo/Insight), environmental monitoring standards
Preferred skills
Cell therapy manufacturing experience, ISO/IEC 17025 or ANSI/NCSL Z540.3 knowledge, 21 CFR Part 11 and GxP familiarity
Technologies
Blue Mountain, Siemens Desigo, Insight, PLCs, HVAC, BMS, QEMS
Responsibilities
Perform preventative, routine, and corrective maintenance of CTUs, process utility systems, and manufacturing/laboratory instruments; Monitor, investigate, and respond to alarms from BMS/QEMS; Support Metrology to investigate OOT events using root cause analysis; Write incident/deviation reports and identify corrective actions; Receive, filter, and execute work order requests; Work with external vendors for equipment service/repair; Provide On-Call support
Seniority
Senior, hands-on IC
