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Marlborough, Massachusetts, United States
Onsite
• 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 work with outside vendors, define technical requirements, follow up on assigned work, and manage deliverables to project needs.
• Excellent presentation, verbal, written communication, organization, and follow-through skills.
• Self-starter with the ability to operate with urgency, ownership, and sound judgment in a dynamic manufacturing environment.
• Demonstrated commitment to safety, PPE requirements, safe work practices, and leading by example in alignment with Repligen R-Values.
Our mission is to inspire advances in bioprocessing as a trusted partner in the production of biologic drugs that improve human health worldwide. Focused on cost and process efficiencies, we deliver innovative technologies and solutions that help set new standards in bioprocessing. The estimated salary range for this role, based in the United States of America is $125,000-$150,000. Compensation decisions are dependent on several factors including, but not limited to an individual's qualifications, location, internal equity, and alignment with market data. Additionally, employees are eligible to participate in one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits such as paid time off, health/dental/vision, retirement benefits and flexible spending accounts. All compensation and benefits information will be confirmed in writing at the time of offer.