Research Technician IV
Joulé
Pittsburgh, PA
Apply
JOB DETAILS
SKILLS
Analysis Skills, Cleanroom, Continuous Improvement, Corrective Action, Current Good Manufacturing Practice (cGMP), Environmental Monitoring, Facilities Management, Facilities and Maintenance, GMP (Good Manufacturing Practices), Gene Therapy, HVAC, ISO (International Organization for Standardization), Inventory Management, Manufacturing Operations, Materials Planning, Patient Safety, Quality Assurance, Regulations, Release Management/Engineering, Restricted Materials, Risk Analysis, Standard Operating Procedures (SOP), Systems Administration/Management, Systems Maintenance, Trend Analysis
LOCATION
Pittsburgh, PA
POSTED
4 days ago
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.
- 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
#M3
#LI-KM1
Ref: #558-Scientific
About the Company
J
Joulé
With extensive scientific, clinical, and healthcare industry experience, Joulé recruiters excel at placing talent across core specialty areas:
- Scientific staffing for hard-to-find skills
Working across every scientific discipline, Joulé places biologists, chemists, scientists, technicians and other specialists.
- Clinical lifecycle recruiting
From research to regulations, safety to statistics, Joulé helps clients manage every stage of the clinical development lifecycle.
- Equipment calibration, maintenance and validation
Laboratory and facility support comes with a total quality commitment backed by ISO 9001:2008 certification.
- National healthcare recruitment
Trust Joulé’s extensive experience in physician, advanced practice provider and executive direct placement search.
COMPANY SIZE
500 to 999 employeesINDUSTRY
Biotechnology/Pharmaceuticals
WEBSITE
https://www.jouleinc.com/