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Clinigen
Malvern, PA, US
Source: Clinigen careers · View original posting
From Clinigen's posting. “We” and “our” refer to the employer.
Clinigen is a rapidly growing global specialty pharmaceutical and services company with a unique combination of businesses. Our divisions operate in a complex global regulatory environment and ensure that vital medicines are delivered securely on time and wherever they are needed in the world.
This position is responsible for working closely with team members to maintain all aspects of the facility and its operating equipment
Equipment Maintenance & Reliability
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.
Vendor & Contractor 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.
Facilities & Safety Compliance
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.
Documentation & Continuous Improvement
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.
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