This gene therapy biotech is currently seeking Facilities Specialists to join their growing team. This nearly created role will be based in Philadelphia and will be responsible for troubleshooting, repairing and maintain facilities that includes infrastructure, utilities and equipment.
•Works under Facility management’s direction to plan, schedule and/or perform all maintenance activities that include routinely Preventive Maintenance (PM) and daily, emerged troubleshooting.
•Performs and oversees scheduled maintenance activities (PMs) and repairs to the utilities systems
•(i.e. HVAC, liquid/gases systems, waste systems, etc.) and other mechanical systems and equipment throughout the facility.
•Perform daily walkthroughs and periodic inspections of the facilities infrastructures that includes buildings, utilities and equipment. Utilize, manage, and schedule outside resources, as required. Maintains Facility documentation in audit ready status at all times.
•Creates and maintains document (i.e. records, reports) related to Facilities work, following GDP (Good Documentation Practices) and other cGMP (Good Manufacturing Practices) when applicable.
•Maintains inventory of basic supplies-spare parts for utilities and process equipment.
•Partakes in the installation, set-up and commissioning required for critical utility systems, process and analytical equipment.
•If necessary, schedules and manages the outside resources when it is required.
•Ensures compliance with safety, site procedures and all current Good Manufacturing Practices (cGMP’s) when it is applicable.
•Fosters Spark Core Values, the teamwork environment and continuously supports the company’s growth and success.
•Other duties as requested or assigned by management.
•1-2 years’ experience in cGMP environment is preferred.
•Previous experience servicing and maintaining building/facilities and process equipment and performing calibration checks on critical utility systems and process equipment
•Able to read electrical and mechanical drawings.
•Proficient with electrical/mechanical test equipment.
•Familiarity with Building Management Systems (BMS) and Computerized Maintenance Management Systems (CMMS).
•Knowledge of OSHA requirements regarding safety, hazardous chemicals, etc.
•Working knowledge of GXP compliance as well as ICH and FDA guidelines.