Senior Manufacturing Engineer

Repligen Corp; Marlborough (MA); Presencial; USD 125.000 - 150.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health/dental/vision

Retirement benefits

Flexible spending accounts

Paid time off

Descripción de la vacante

Repligen Corp in Marlborough, MA seeks a Senior Manufacturing Engineer to lead electro-mechanical projects, drive schedules, and coordinate cross-functional teams for manufacturing readiness, process stability, and documentation control in an ISO-regulated environment.

BS in Mechanical/Manufacturing/EM Engineering with 5–7+ years in fast-paced, regulated settings; strong PM, problem-solving, and hands-on capabilities. SAP/SolidWorks experience is preferred.

Formación

• BS degree in Mechanical Engineering, Manufacturing Engineering, Electro-mechanical Engineering, or a related technical discipline.
• 5–7+ years of engineering experience in a fast-pace manufacturing, systems build, product development, or regulated environment.
• Demonstrated project management capability with planning, prioritization, schedule development, action tracking, risk escalation, and cross-functional execution.
• Strong cross-functional communication skills to lead and align stakeholders.
• Strong electro-mechanical aptitude to troubleshoot and improve hardware, systems assemblies, and interfaces.

Responsabilidades

• Lead manufacturing engineering projects from scope definition through execution with timelines and risk tracking.
• Develop internal project schedules with cross-functional owners and drive accountability for actions.
• Partner with Manufacturing, Service, Product Management, R&D, Quality, Planning, Supply Chain, and vendors as technical engineering lead.
• Troubleshoot and improve hardware and systems builds (mechanical, electrical, fluidics, test equipment).
• Review design documents (P&IDs, URS, schematics) during quotes, transfers, and new product introductions.
• Manage creation, update, and release of manufacturing docs via Engineering Change process.
• Develop practical solutions for hardware integration, workflow, and process readiness.
• Train and support manufacturing personnel on new processes and test methods.
• Support technology transfers from other sites to Marlborough Manufacturing.
• Identify and resolve process, quality, and manufacturability issues; support CAPAs.
• Participate in best practices and continuous improvement initiatives and promote EHS culture.
• Process improvement experience; data analysis and SAP familiarity are preferred.

Conocimientos

Project management

Cross-functional teamwork

Electro-mechanical aptitude

Communication skills

Self-starter

Educación

BS degree in Mechanical Engineering or related

Herramientas

SolidWorks

SAP

Fixture design

Descripción del empleo

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-pace 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.

Process improvement experience. Data analysis/visualization skillsand familiarity with systems such as SAP are preferred.

• 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.

Thank you for your interest in Repligen! Working at Repligen means being part of a team that is excited to find new and creative ways to overcome challenges in bioprocessing — and to help our customers make a difference in the world.