Overview

The Facility Manager is responsible for overseeing the day-to-day requirements necessary for maintaining the uBriGene facility in a critical state of operational readiness. The role will be responsible for the management of Facility Engineering, Metrology, and Facility Cleaning and Service Technicians. The role will drive collaboration with the departmental/organizational partners to provide clarity and facility readiness for the cGMP manufacturing cleanrooms, site equipment, and continuous improvement projects.

Key Responsibilities

· Enable day to day operation and provide direction for the Facilities Engineering, Metrology, and Facility Cleaning activities.

· Lead and participate in the development of user specifications for equipment, utilities, and mechanical systems.

· Lead and participate as assigned in the design, build-out, commissioning and validation of the cGMP production equipment and facility.

· Coordinate, perform and/or oversee assigned facilities project work.

· Author and/or contribute to deviations/investigations, Corrective/Preventive Action initiatives, Change Control procedures, technical protocols, and topical planning.

· Maintain calibration and PM schedules.

· Maintain facility cleaning schedules.

· Participate in on call schedule.

· Provide technical service and support to all departments.

· Ensure compliance with all cGMP, state and federal requirements and all applicable health and safety regulations (OSHA).

· Ensure processes are documented, current, and accurate as per company procedures and all cGMP requirements.

· Other duties as assigned by the Management Team.

Qualifications and Experience

· Minimum of 4+ years' experience leading or supervising activities in a cGMP biotech or pharmaceutical environment.

· B.S. in an Engineering discipline (Mechanical, Chemical, Facilities).

· Hands-on experience with equipment setup and calibration.

· Excellent communication skills, both oral and written.

· Experience and understanding of regulatory requirements as pertain to a cGMP manufacturing facility.

· Experience with leading or participating in Quality incident investigations that resulted in deviations or CAPA responses.

· Experience with Cell and Gene Therapy.