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Facilities Operations Supervisor/Manager

2 months ago

Raleigh, United States CARsgen Therapeutics Full time

Key Responsibilities:

• Organize and manage daily work to keep the GMP plant, warehouse, QC lab and PD lab in a smooth operational status. Resolve issues in a timely manner.

• Manage external contractors and suppliers to reliably support facility/utility operations

• Effectively use CMMS/EMS for maintenance operations; help with improvement with systems

• Perform Daily walk-throughs to proactively identify issues and seek continuous opportunities to improve efficiency and reduce cost

• Respond to afterhours urgent facility problems and resolve them

Requirements:

• Minimum of 6 years of experience of facility & utility maintenance under GMP environment.

• Experience with BMS (Building Management System) and EMS (Environmental Monitoring System)

• Experience with utility systems, clean air, pharmaceutical gasses, HVAC systems

• Experience maintaining grade B/C/D clean rooms

• Solid mechanical and engineering skills to troubleshoot HVAC, Boiler, Chiller, and Compressed air systems. Knowledge with Liquid Nitrogen storages a plus.

• Responsible for authoring and maintenance of standard operating procedures (SOP) and equipment forms/logbooks for the department

• Experience working within a CMMS (Blue Mountain, SAP, Maximo, etc.) and managing PM/Corrective work orders and associated documentation.

• Experience handling deviations, CAPAs, and Change Controls associated with facility or engineering

• Ability to support internal and external audits.

• Effective communication and organizational skills.

• Flexibility to perform various tasks and ability to prioritize based on business needs.

• Ability to thoroughly review controlled documentation for clarity and traceability.

EDUCATION/EXPERIENCE

• Associates Degree required. Batchlor’s degree preferred. Minimum of 6 years of experience maintaining facility and utility of GMP plant.

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