Senior Manufacturing Engineer at Repligen in Marlborough, MA

Job description

The Senior Manufacturing Engineer will report to the Engineering Manager for Systems and Hardware and serve as a technical project lead for Marlborough-based product lines. This role combines project management, cross-functional execution, and hands-on electro-mechanical engineering aptitude to support manufacturing readiness, process stability, documentation control, and technology transfer activity in an ISO-regulated environment. • Lead manufacturing engineering projects from scope definition through execution (including timelines, action tracking, stakeholder alignment, risk identification, and timely status reporting). • Develop internal project schedules with input and commitment from cross-functional owners, then drive accountability for actions, decisions, and deliverables. • Partner with Manufacturing, Service, Product Management, R&D, Quality, Planning, Supply Chain, and external vendors as the technical engineering lead for assigned systems and processes. • Apply strong electro-mechanical aptitude to troubleshoot, improve, and support complex hardware and systems builds (including mechanical assemblies, electrical interfaces, fluidic paths, test equipment, and integrated system configurations). • Review and provide technical feedback on design documents (P&IDs, URS documents, schematics, drawings, models, technical data sheets) during quotation, custom system builds, technology transfers, and new product introductions. • Manage creation, update, and release of manufacturing documentation (SOPs, work instructions, test procedures, batch records, bills of material, drawings, models, and system configuration documentation) through the Engineering Change process. • Develop practical, application-based solutions for hardware integration, manufacturing flow, work cell build-out, test equipment definition, and process readiness. • Train and support manufacturing personnel on new or revised processes, documentation, test methods, and system-build expectations. • Support technology transfers from other Repligen sites to Marlborough Manufacturing, including build readiness, documentation gaps, fixture/test needs, training, and process stabilization. • Identify, investigate, and resolve process, quality, and manufacturability issues for assigned products and processes, including support for customer issue investigations and corrective actions. • Participate in the creation and maintenance of departmental best practices, standard work, and continuous improvement initiatives. • Promote Repligen’s EHS culture by supporting safe work practices, identifying hazards or near misses, and participating in corrective actions and process improvements. Education and/or Work Experience Requirements: • BS degree in Mechanical Engineering, Manufacturing Engineering, Electro-Mechanical Engineering, or a related technical discipline. • 5-7+ years of engineering experience in a fast-paced manufacturing, systems build, product development, or regulated manufacturing environment. • Demonstrated project management capability. Including planning, prioritization, schedule development, action tracking, risk escalation, and execution through cross-functional teams. • Strong cross-functional communication skills with the ability to lead, influence, and align internal and external stakeholders. • Strong electro-mechanical aptitude with demonstrated ability to understand, troubleshoot, and improve complex hardware, systems assemblies, mechanical interfaces, electrical components, fluidic systems, and test setups. • Familiarity with process and design documentation (P&IDs, URS documents, schematics, drawings, technical data sheets, work instructions, SOPs, batch records, and bills of material). • SolidWorks experience with component and assembly drawings preferred. • Experience with hardware and systems design/assembly, fluidic testing, sheet metal fabrication, machined metal/plastic parts, fixture design, or test equipment selection preferred. • Able to