Role Overview

The CAR-T Facility Cleaning Lead is an exempt level position working within Maintenance and Metrology team. This individual will be responsible for managing the 3^rd shift cleaners to ensure the facility meets aseptic requirements for Manufacturing and Quality Control Labs. This person will communicate and provide updates 1^st shift facilities and operations teams. The lead will work closely with the cleaning team to ensure all 3^rd shift cleaners are compliant with the training and general manufacturing practices.

Key Responsibilities

• Lead the 3^rd shift cleaning team to ensure facility readiness for manufacturing operations and quality control labs next shift.
• Communicate with all key stakeholders (MFG, FAC, QC, etc..) any issues or concerns with facility cleanings.
• Performs daily walkthroughs of the facility to ensure all proper daily, weekly or monthly cleanings are being executed per schedule
• Enforce all departmental and organizational policies and procedures.
• Ensures proper cleaning materials, parts and spare parts are identified and available for daily, weekly and monthly cleanings.
• Ensure collaboration with key stakeholders and functions.
• Supports the planning, coordination, preparation, and timely execution of cleaning for maintenance shutdowns.
• Inspect and evaluate the physical appearance of the facility and coordinate with site management for any cleanings / repairs.
• Report and address any unsafe conditions or environmental concerns.
• Ability to interact with all levels within the organization.

Requirements

• High school diploma or GED required.
• Associate's degree from a two-year college or technical school preferred.
• A minimum of 3-5 years related experience in GMP facilities. Good understanding of facility cleanings per agency guidance. Working in a Pharmaceutical / GMP facility experience preferred
• An ability to build strong partnerships with internal customers and effectively integrate with external vendors to drive facility cleaning operations.
• Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively.
• Ability to think critically, and demonstrated troubleshooting and problem-solving skills
• Manage and work with vendors for routine equipment requirements and breakdowns.
• cGMP manufacturing
• Cleaning and facilities management
• Proficient with Manufacturing Execution System (MES)
• Quality Management knowledge, including Change control, Deviation, and CAPA's.
• EHS and regulatory standards (e.g. EPA, OSHA and DEA)
• Bilingual preferred (English / Spanish).

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