What are the responsibilities and job description for the GMP Project Engineer position at Stark Pharma Solutions Inc?
Position: GMP 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.
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.
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