Facilities Engineer

About the Role

This position is responsible for supporting operations by ensuring that the building and utilities are properly maintained to support GMP manufacturing and general facility operations. This support includes performing building and utility equipment inspections, diagnosing problems, scheduling, coordinating and overseeing third-party maintenance activities, performing hands-on maintenance, and completing and reviewing GMP and non-GMP documents relating to change controls. The role requires creative and collaborative interfacing with CMC stakeholders, facility operations, and facility engineering teams, with a focus on championing effective equipment/utility maintenance practices and strict adherence to GMP requirements.

Responsibilities

• Understand core CMC goals and operations to align maintenance strategies with stakeholder requirements and business needs.
• Oversee the building and utility maintenance program in accordance with GMP and GDP requirements to ensure equipment reliability and inspection readiness.
• Assess repair effectiveness against preventive maintenance (PM) strategies and enhance PMs as needed.
• Investigate equipment and utility deficiencies using root cause analysis and technical expertise to resolve issues.
• Schedule, oversee, and verify third-party maintenance activities for manufacturing equipment, utilities, and building systems.
• Obtain and process vendor quotes for repairs and services.
• Lead or assist with building/utility-related projects.
• Respond to after-hours building and utility alarms on a rotational basis.
• Perform daily inspections of buildings and utility equipment to identify and document areas of concern.
• Manage the compressed gas program.
• Initiate and participate in GMP investigations, deviations, CAPAs, and change controls related to building, utility, and equipment repairs.
• Develop and modify SOPs related to equipment maintenance.
• Assist with building support services and perform minor maintenance tasks (e.g., patching, painting, filter replacement).
• Supervise third-party service providers, ensuring compliance with EHS/GMP requirements.
• Align maintenance activities with stakeholder schedules to avoid disruptions.
• Maintain the preventive maintenance program and review equipment history for reliability concerns.
• Identify and maintain critical spare parts and standby equipment.
• Ensure vendor service contracts are in place and manage P.O.s.
• Review BAS information to assess HVAC performance and acknowledge alarms in the BMS.
• Lead or assist with Facilities and Engineering projects, including equipment installations and HVAC upgrades.
• Organize and document maintenance records in an inspection-ready state.
• Champion GMP compliance and maintenance best practices.
• Perform daily, weekly, and quarterly inspections, document findings, and initiate work orders.
• Oversee compressed gas changes on process equipment.
• Assist with building support services (e.g., setting up conference rooms, events, inventory management).
• Perform other duties as assigned to support company growth.

Qualifications

• Maintenance experience with a wide range of building and equipment systems in a GMP manufacturing environment.
• Experience with GMP Quality Management systems (deviations, CAPAs, etc.).
• Strong ability to analyze raw data, assess results, and determine appropriate actions.
• Proficiency in completing GMP documentation related to maintenance activities.
• Ability to organize maintenance requirements using Excel or software tools to meet deadlines.
• Strong organizational skills and resilience to manage conflicting priorities and sudden scheduling changes.
• Capability to work independently and collaboratively in a team environment.
• Prior experience in the biotechnology or pharmaceuticals industry.

Physical Demands

• Frequently required to stand, walk, sit, talk, or hear.
• Occasionally required to lift up to 30 pounds.
• Specific vision abilities: close vision, color vision, and ability to adjust focus.

Work Environment

The noise level in the work environment is usually quiet. Some maintenance activities may be performed in a clean room, requiring gowning.