Specialist, Facilities

The Specialist, Facilities is responsible for facilities, utilities and production and laboratory assets across multiple production sites producing clinical and commercial drug products. This role involves providing technical expertise for asset operation and troubleshooting, and utilization of a Computerized Maintenance Management System (CMMS) to manage asset data, asset labelling, asset status, and to coordinate and execute preventative and corrective maintenance, calibration and certification activities to ensure compliant and reliable operations to support production requirements to meet customer needs. They will also be responsible for managing and executing various projects in support of facility and utility system operations.

Physical Demands & Work Conditions

• Production Associates: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.
• Must meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for up to 3 consecutive hours at a time, minimal movement in the cleanroom, and working with or around human blood, blood-derived materials, cells, other biological materials, and alcohol-based sprays. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.
• Must be comfortable regularly participating in video-based meetings.

Job duties and responsibilities include:

• Analyze, troubleshoot, and resolve system/equipment performance, malfunctions, or failures

• Track and report on equipment downtime, failure trends and develop corrective actions to prevent recurrence

• Planning, scheduling and coordinating onsite and offsite preventative and corrective maintenance, calibration and certification activities to be completed by service providers

• Review and approval of service provider documentation, and completion and closeout of tasks in the CMMS

• Ensure that facilities, utilities, production and laboratory assets are maintained, calibrated, and certified to applicable GMP standards

• Collaboration with peers in the continuous improvement of equipment standards, practices, specifications, procedures, qualifications and business processes

• Lead and/or participate in the identification and development of solutions to stabilize and optimize equipment systems

• Execution of facility preventative and corrective maintenance tasks, small projects and continuous improvements

• Onboarding new assets and maintaining current assets in the CMMS, including asset identification and status, labelling, and assigning required maintenance, calibration and certification plans

• Other duties as assigned

Education & Experience Requirements:

• Bachelor’s degree in Engineering, Life Sciences, Facility Management or equivalent technical experience

• 4 years of experience in GMP manufacturing facility, including equipment operation and troubleshooting, and facilities and asset maintenance execution in a GMP manufacturing facility

• Experience in analyzing, managing, and reporting reliability metrics, and managing assets and maintenance activities using a CMMS system

• Experience coordinating onsite and offsite maintenance, calibration and certification activities completed by service providers

• Experience in managing and executing facility and utility projects including repairs, improvements and new installations.

Personal Qualities & Physical Demands:

• Ability to multitask and handle multiple responsibilities simultaneously; able to prioritize

• Demonstrates strong work ethic, curiosity to learn and contribute in a fast-paced collaborative environment

• Willing to support sites after-hours on an as needed or on-call basis

• Strong interpersonal skills and ability to communicate effectively

• Strong problem-solving and critical thinking skills to support making decisions in a timely manner, and desire to improve upon established processes

• Ability to gown and work in clean room areas

• Ability to work in a collaborative manner, independently and as part of a team

• Ability to work in a fast-paced start-up environment while following documented procedures and instructions.

• Ability to work for extended periods of time at a computer

• Occasional need to ascend/descend stairs within the workspace; job requires sitting, standing/walking