Facilities and Maintenance Lead Technician - (Pharma/GMP)

Clinigen • Malvern, PA

12d • Onsite

About The Position

This position is responsible for working closely with team members to maintain all aspects of the facility and its operating equipment. The role involves performing and coordinating maintenance on facility and operational equipment, troubleshooting issues, ensuring equipment remains in a qualified state, serving as the primary site contact for facility and maintenance vendors, and promoting a strong safety culture. The technician will also maintain maintenance records, support investigations and continuous improvement initiatives, and participate in an on-call rotation for emergencies.

Requirements

• High school diploma and/or GED
• 2-4 years of facilities-related work experience
• 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
• Highly computer literate; experience operating with all Microsoft Office software
• Ability to operate office equipment (telephone, calculator, photocopier, fax, and scanning machines)
• Confidentiality of all clients’ proprietary and pharmaceutical related information is essential

Nice To Haves

• 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, etc.
• OSHA regulation knowledge is desired
• Experience with MSDS documentation preferred
• Knowledge of pharmaceutical manufacturing/packaging operations or principles and practices involved in clinical trials is preferred
• Detail orientated 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
• Other company proprietary software

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.

Benefits

• The culture. Thanks to our diverse opportunities for engagement and involvement, every colleague’s Clinigen experience can be a bit different, and we’re proud of that. We work hard to ensure our company culture is inclusive to people from all backgrounds and social styles.
• The transparency with leadership. All colleagues can share anonymous feedback with leadership on a weekly basis through our employee engagement platform. We use this feedback to inform our actions and decisions. We’ve been able to take steps to continuously improve how we do things at Clinigen.
• The benefits. We take pride in having a broad range of activities, systems, and programs that provide a competitive benefit offering and build a culture of celebrating success.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED