Facilities & Equipment Project Engineer

Position: Facilities & Equipment Project Engineer Location: Canton, MA (Onsite)

Experience: 3–5 years

Role Overview

This role supports a major facility expansion initiative aimed at increasing production capacity, improving equipment reliability, and preparing the site for higher-volume GMP operations. The engineer will oversee multiple capital projects, focusing on mechanical systems, facility upgrades, and equipment installation in regulated environments.

Key Responsibilities

• Lead and support multiple GMP facility and equipment modification projects, ensuring all work is delivered within budget, scope, and timeline.

• Interpret and work from mechanical drawings, electrical schematics, and P&ID diagrams with strong technical accuracy.

• Manage and coordinate subcontractors responsible for building modifications such as casework installation, painting, refurbishment, and construction activities.

• Ensure all projects meet FDA, GMP, and ISO regulatory requirements throughout design, installation, commissioning, and qualification.

• Partner closely with manufacturing, quality, facilities, and engineering teams to align project activities with operational needs and compliance expectations.

• Support system start-up, commissioning, qualification, and documentation processes for all new or upgraded equipment and facility spaces.

• Coordinate execution of project work during non-traditional hours, including evenings and weekends, to reduce operational disruption.

• Drive improvements in equipment reliability, facility readiness, and overall operational performance to support increased production targets.

• Oversee the construction or refurbishment of specialized rooms such as ISO-classified cleanrooms, cold rooms, incubator spaces, and laboratory areas.

• Support upgrades and installations of critical temperature-controlled environments, including refrigeration systems and warehouse freezers.

Key Projects You Will Support

• Build-out of an ISO 7 Cold Room.

• Refurbishment of an existing small laboratory space.

• Construction and qualification of an ISO Class 5 Suite.

• Conversion of a storage room into a final product incubator room.

• Upgrades and replacements for refrigeration and HVAC-related systems.

• Installation and qualification of a -20°C warehouse freezer.

Requirements

• • 3–5 years of hands-on GMP project engineering experience.

• • Mechanical engineering background with a superintendent-style approach to field oversight and contractor management.

• • Ability to read and interpret mechanical, electrical, and P&ID drawings with confidence.

• • Strong organizational abilities with experience running multiple projects simultaneously in a regulated environment.

• • Excellent communication skills with the ability to work cross-functionally at all levels.

• • Proven experience coordinating subcontractors, trades, and construction teams.

• • Experience working in ISO-classified areas, including environments up to ISO Class 5.

• • Background in temperature mapping for controlled temperature environments, cold rooms, and freezers.

• • Ability to work 100% onsite in Canton, MA.

• • Willingness to work Friday evenings and Saturday daytime shifts when needed to avoid disruptions to operations.