Facilities Maintenance Associate III

University of Colorado Anschutz Medical Campus

Department: Chancellor’s Office – Gates Biomanufacturing Facility

Job Title: Facilities Maintenance Associate III

Position #:00738134 – Requisition #:37580

Job Summary:

This position is a full-time, senior level professional position at the Gates Biomanufacturing Facility located on the Anschutz Medical Campus and serves on the Facilities team.  This position will be responsible for coordinating facility operations, implementing and improving facilities specific systems and functions including facility operations, maintenance and troubleshooting of mechanical, electrical and scientific equipment. The Facilities Associate will work closely with the Facilities team reporting to the Facilities Manager.

The Facilities Associate supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) and will serve as the primary point of contact for GMP facility-related items to Quality Assurance and Site Facilities & Engineering. This includes overseeing the facility cleaning programs, coordinating facility maintenance events (planned and unplanned), ensuring accuracy of asset and service records in facility quality systems, and providing project management support for Facilities Department projects. This is a hands-on position and will require performing maintenance and other manual tasks on an as-needed basis. 

At the Senior level this role will be responsible for independent Facilities maintenance and assist in the execution of a quality/cGMP-based facility program for the contract manufacturing of protein biologics and regenerative medicine therapies for phase 1 and 2 clinical trials. 

Key Responsibilities:

Project Management, Process Improvement & Regulatory Compliance - 20%

• Analyze the performance and health of the maintenance and calibration systems through evaluation of the reports, managing issues to resolution and in conformance with quality metrics and compliance requirements.

• Manage traceability and status requirements in accordance with site Quality Management System (QMS) standards for equipment and instruments.

• Perform facility inspections and report to Facilities leadership on conditions affecting operations.

• Participate in the risk management program regarding equipment and instruments.

• Lead facilities related programs to meet key performance indicators (KPI) to quality objectives.

• Oversee improvement, installation, repair projects, and lab start up and build out.

• Provide exceptional customer service to users of the facility.

• Report and take guidance and direction from the Facilities Manager, assisting in large scale capital projects, annual shutdowns, and other events.

• Participate in new asset onboarding and logistics as per internal validation and qualification procedure to avoid downtime during production.

• Schedule and coordinate qualified vendor visits proactively based upcoming calibration/maintenance query from Quality management system; Facilitate vendor arrival, parking, receiving and hand off.

• Review and track service contracts for cGMP maintenance services. Actively participate in upgrading contract terms and maintaining vendor relationship.

• Work with finance and procurement department to have vendor service PO generated.

• Participate in generating KPI and facility/utility relat