Facility Technician

Title: Facility Technician
Location: Onsite, Pittsburgh, PA 15219
Type: Direct-Hire/Permanent
Hours: Standard business hours
Start: ASAP
Overview:
Join a cutting-edge cell and gene therapy (CGT) team as a Facility Technician to support the Facility Manager in maintaining facility systems, utilities, and equipment in a qualified and validated state in compliance with current Good Manufacturing Practices (cGMP). Ensures dean room environments remain under controlled conditions by coordinating environmental monitoring, facility controls, and contamination-prevention measures to safeguard product quality and patient safety.
Responsibilities:

• Coordinates day-to-day activities to maintain overall facility control, including the environment, equipment, and alarms.
• Responsible for gowning and material transfer for GMP (Good Manufacturing Practice) operations.
• Conducts environmental monitoring on a schedule and frequency determined by a documented risk assessment, appropriate ISO classification levels, and internal policies.
• Coordinates cleaning and sanitization activities within the cleanroom.
• Manages the release of materials following planned or unplanned maintenance activities.
• Collects and analyzes environmental and utility sampling data to identify trends and implement appropriate actions.
• Orders, receives, quarantines, inspects, releases, and restocks raw materials according to established Standard Operating Procedures (SOPs) and controlled material specifications.
• Assists in the storage of retention samples and final products according to established procedures and conditions.
• Manages shipments and deliveries and maintains an accurate inventory database of raw materials, samples, and products.
• Serves as the primary point of contact for facility alarms related to HVAC (Heating, Ventilation, and Air Conditioning), Biological Safety Cabinets (BSCs), room control equipment, and utilities. Reports all excursions to Quality Assurance (QA) and participates in investigations of non-conformances in compliance with quality procedures, policies, and regulations.
• Assists QA in creating and implementing corrective and preventative action plans to address concerns or continuous improvements, and provides measures of effectiveness.

Requirements:

• Two years of relevant experience in facility maintenance and coordination.
• A Bachelor's degree in a scientific discipline is preferred, but at least an Associate degree with demonstrated knowledge of facility management and GMP-regulated environments is required

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