Facilities and Maintenance Lead Technician - (Pharma/GMP)
Clinigen · Malvern, PA · 1 mo ago
On-siteOTHRFull-time
About the role
This position is responsible for working closely with team members to maintain all aspects of the facility and its operating equipment.
Responsibilities
- Perform and coordinate preventive, predictive, and corrective maintenance on facility and operational equipment including HVAC, refrigeration, compressed air, temperature monitoring systems, utilities, and production equipment
- Troubleshoot equipment and facility issues, implement corrective actions, and support equipment installation, qualification, validation, and commissioning activities
- Ensure equipment remains in a qualified, calibrated, and operational state through effective maintenance and calibration management
- Serve as the primary site contact for facility and maintenance vendors, including HVAC, pest control, cleanroom certification, calibration, utilities, fire protection, security, and equipment repair providers
- Schedule, oversee, and evaluate contractor activities to ensure work is completed safely, compliantly, and in accordance with site requirements
- Maintain vendor-related documentation, service records, work orders, and contractor qualification activities
- Promote a strong safety culture and ensure all maintenance and contractor activities comply with EHS, GMP, and company requirements
- Support facility compliance activities including alarm testing, emergency response drills, inspections, and contractor safety programs
- Participate in the on-call rotation and respond to facility alarms, equipment failures, and emergency situations as required
- Maintain maintenance records, logs, and facility documentation in compliance with cGMP and GDP requirements
- Support investigations, deviations, CAPAs, change controls, SOP development, and continuous improvement initiatives related to facilities and equipment reliability
Requirements
- High school diploma and/or GED
- 2–4 years of facilities-related work experience
- Experience in a cGMP environment preferred
- Knowledge of validation and calibration methodology is preferred
- Experience or certification in controls helpful
- Knowledge and functional understanding of temperature monitoring, security, and fire prevention systems
- OSHA regulation knowledge is desired
- Knowledge and understanding of how to use calibration equipment, hand tools, power tools, etc.
- Must possess a detailed, proactive approach to management in problem solving of daily operations
- Must be mechanically inclined to handle the following types of equipment: pallet jack, vacuum seal chamber, scales, carding/blistering machines, cryogenic nitrogen chambers, large-scale refrigerators/freezers, time/temperature-dependent equipment
- Experience with MSDS documentation preferred
- Knowledge of pharmaceutical manufacturing/packaging operations or principles and practices involved in clinical trials is preferred
- Detail oriented to produce accurate work while making timely and sound decisions
- Ability to develop and maintain effective working relationships with co-workers at all levels of the organization
- Exceptional oral and written communication skills and active listening ability
- Excellent time management skills for working within a fast paced, ever-changing environment
- Self-motivated learner to critically evaluate situations and adapt quickly in making timely and independent decisions
- Confidentiality of all clients' proprietary and pharmaceutical related information is essential
- Highly computer literate; experience operating with all Microsoft Office software
- Ability to operate office equipment (telephone, calculator, photocopier, fax, and scanning machines)