Jobs · OTHR · Pennsylvania

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)

Similar jobs