Overview

We are undertaking a major initiative to expand at the Canton, MA facility, increasing production from 40,000–50,000 units to 100,000 units next year. This effort includes improving equipment reliability, replacing aging assets, and expanding facility space to support higher-volume GMP operations.

We are hiring a GMP Project Engineer with a strong mechanical engineering foundation and a superintendent-style background to manage multiple facility modification and equipment installation projects.

Key Projects You Will Support:

You will lead or support approximately six capital projects ranging from $50K–$500K, including:

• Build-out of an ISO 7 Cold Room
• Refurbishment of an existing small laboratory space
• Construction and qualification of an ISO 5 Suite
• Conversion of a storage room into a final product incubator room
• Upgrades and replacements to refrigeration systems
• Installation of a -20°C warehouse freezer

Project Engineer Responsibilities:

• Plan, coordinate, and execute GMP facility and equipment projects within budget and timeline
• Interpret and work from mechanical, electrical, and P&ID drawings
• Oversee subcontractors performing building modifications, including casework, painting, and refurbishment construction
• Ensure projects comply with FDA, GMP, and ISO standards
• Collaborate cross-functionally with manufacturing, quality, facilities, and engineering teams
• Support system start-up, commissioning, qualification, and documentation
• Coordinate work during required non-traditional hours to minimize impact on operations
• Drive improvements in equipment reliability and facility readiness to meet increased throughput goals

Requirements:

• 3–5 years of GMP project engineering experience
• Mechanical engineering background with superintendent-style hands-on oversight
• Ability to read and interpret electrical drawings and P&ID diagrams
• Strong organizational and project management skills
• Excellent cross-functional communication abilities
• Experience working with subcontractors and trades
• Experience working in ISO-classified environments (up to ISO Class 5)
• Experience with temperature mapping for controlled temperature environments (CTE) and freezer rooms
• Ability to work onsite 100% of the time in Canton, MA
• Willingness to work Friday evenings and Saturday daytime shifts as required