What are the responsibilities and job description for the 0018V6067 GMP Project Engineer (Mechanical Focus) position at Two River Consulting Partners?
0018V6067 GMP Project Engineer (Mechanical Focus) Please contact Amanda Mazza, amanda@tworivercp.com***FTE or Contractor***KEY RESPONSIBILITIESWe 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 RoomRefurbishment of an existing small laboratory spaceConstruction and qualification of an ISO 5 SuiteConversion of a storage room into a final product incubator roomUpgrades and replacements to refrigeration systemsInstallation of a -20°C warehouse freezerProject Engineer Responsibilities:Plan, coordinate, and execute GMP facility and equipment projects within budget and timelineInterpret and work from mechanical, electrical, and P&ID drawingsOversee subcontractors performing building modifications, including casework, painting, and refurbishment constructionEnsure projects comply with FDA, GMP, and ISO standardsCollaborate cross-functionally with manufacturing, quality, facilities, and engineering teamsSupport system start-up, commissioning, qualification, and documentationCoordinate work during required non-traditional hours to minimize impact on operationsDrive improvements in equipment reliability and facility readiness to meet increased throughput goalsRequirements:3–5 years of GMP project engineering experienceMechanical engineering background with superintendent-style hands-on oversightAbility to read and interpret electrical drawings and P&ID diagramsStrong organizational and project management skillsExcellent cross-functional communication abilitiesExperience working with subcontractors and tradesExperience working in ISO-classified environments (up to ISO Class 5)Experience with temperature mapping for controlled temperature environments (CTE) and freezer roomsAbility to work onsite 100% of the time in Canton, MAWillingness to work Friday evenings and Saturday daytime shifts as requiredLOCATIONOn-site in Canton, MAEMPLOYMENT Competitive C2C or FTE Powered by JazzHRpR9qPON8SK
Salary : $81,400 - $111,000