Senior Manager, Engineering

Repligen Corp; EE. UU.; Presencial; USD 140.000 - 160.000; Jornada completa

Descripción de la vacante

Repligen Corp is seeking a Senior Manager of Process and Manufacturing Engineering in Bothell, WA. You will lead process, manufacturing, and sustaining engineering activities, driving capability, quality, and productivity across the product lifecycle.

You will partner with Manufacturing, Quality, R&D, and OT to advance Manufacturing 4.0, implement standards, and deliver scalable, repeatable processes. Strong leadership and communication are essential.

Formación

• Bachelor's or Master's degree in Engineering (Chemical, Mechanical, Industrial, or related).
• 8+ years of engineering experience in manufacturing environments, including 4+ years of people leadership experience.
• Demonstrated experience leading Process and/or Manufacturing Engineering teams and cross-functional technical initiatives across complex organizational environments.
• Strong expertise in process development, validation, and optimization.
• Experience with lean manufacturing, statistical process control, and continuous improvement systems.
• Demonstrated ability to lead cross-functional initiatives, influence stakeholders, and deliver measurable business results.
• Strong communication and stakeholder management skills, with the ability to build effective partnerships across functions and levels of the organization.
• Working knowledge of ERP systems (SAP or Oracle), CAD tools, and Microsoft Office applications.

Responsabilidades

• Serve as a senior technical leader for Process and Manufacturing Engineering, providing technical direction, enabling sound decision-making, and supporting engineering trade-offs and escalations.
• Translate business and operational priorities into engineering plans, project roadmaps, and capability improvements that align with organizational objectives.
• Implement and maintain engineering standards, best practices, and governance across supported sites while driving consistency and alignment.
• Drive a culture of operational excellence, technical rigor, disciplined execution, continuous improvement, and proactive problem-solving.
• Lead process characterization, validation, and control strategy development across manufacturing operations.
• Lead and coordinate equipment design, selection, installation, commissioning, and qualification activities, including URS, FAT, SAT, IQ/OQ/PQ.
• Drive performance improvements through automation, workflow optimization, error-proofing, and data/AI-enabled tools to increase OEE, throughput, yield, and labor productivity.
• Lead engineering support for new product introductions, process scale-up, and technology transfers into manufacturing, partnering effectively across functions and sites.
• Ensure engineering solutions meet applicable regulatory, quality, safety, and compliance requirements while balancing business needs and risk.

Conocimientos

Process development

Leadership

Lean manufacturing

Statistical methods

Automation

Data analytics

Educación

Bachelor's or Master's in Engineering

Herramientas

SAP/Oracle ERP

CAD tools

Microsoft Office

Descripción del empleo

Responsibilities & Qualifications

The Senior Manager, Process and Manufacturing Engineering is responsible for leading process, manufacturing, and sustaining engineering activities. The Senior Manager ensures manufacturing operations are efficient, reliable, repeatable, and scalable from technology transfer through full product lifecycle sustaining engineering. In close partnership with Manufacturing, Quality, R&D, and OT, this leader drives process capability, equipment performance, product quality, and productivity while advancing Manufacturing 4.0 and operational excellence across the business.

This role is expected to model our Leadership Behaviors-Integrity & Compliance, Customer Focus, Collaboration, Courage, Team Empowerment, and Accountability & Results-in all aspects of work. This is an onsite position based in Bothell, WA.

Leadership & Strategy

• Serve as a senior technical leader for Process and Manufacturing Engineering, providing technical direction, enabling sound decision-making, and supporting engineering trade-offs and escalations.


• Translate business and operational priorities into engineering plans, project roadmaps, and capability improvements that align with organizational objectives.


• Implement and maintain engineering standards, best practices, and governance across supported sites while driving consistency and alignment.


• Drive a culture of operational excellence, technical rigor, disciplined execution, continuous improvement, and proactive problem-solving.

Engineering

• Lead process characterization, validation, and control strategy development across manufacturing operations.


• Ensure production processes and equipment are capable, efficient, reliable, scalable, and aligned with business and customer requirements.


• Lead and coordinate equipment design, selection, installation, commissioning, and qualification activities, including URS, FAT, SAT, IQ/OQ/PQ.


• Drive performance improvements through automation, workflow optimization, error-proofing (poka-yoke), and data/AI-enabled tools to increase OEE, throughput, yield, and labor productivity.


• Ensure engineering and design documentation (BOMs, routings, drawings, specifications, and technical files) is accurate, current, and controlled.


• Lead engineering support for new product introductions, process scale-up, and technology transfers into manufacturing, partnering effectively across functions and sites.


• Ensure engineering solutions meet applicable regulatory, quality, safety, and compliance requirements while balancing business needs and risk.

Talent Development

• Manage, develop, and mentor Process and Manufacturing Engineers and technical experts, fostering growth and long-term capability development.


• Build team capability in advanced manufacturing, process modeling, automation, problem solving, and statistical methods.


• Foster a high-performance culture focused on accountability, inclusion, technical excellence, project execution, continuous improvement, collaboration, and data-driven decision-making.

Qualifications

• Bachelor's or Master's degree in Engineering (Chemical, Mechanical, Industrial, or related discipline).


• 8+ years of engineering experience in manufacturing environments, including 4+ years of people leadership experience.


• Demonstrated experience leading Process and/or Manufacturing Engineering teams and cross-functional technical initiatives across complex organizational environments.


• Strong expertise in process development, validation, and optimization.


• Experience with lean manufacturing, statistical process control, and continuous improvement systems.


• Demonstrated ability to lead cross-functional initiatives, influence stakeholders, and deliver measurable business results.


• Strong communication and stakeholder management skills, with the ability to build effective partnerships across functions and levels of the organization.


• Working knowledge of ERP systems (SAP or Oracle), CAD tools, and Microsoft Office applications.

Preferred Experience

• Experience in regulated manufacturing environments, including biopharmaceutical, medical device, or similar industries.


• Knowledge of GMP manufacturing, validation practices, and quality systems.


• Experience with digital manufacturing, automation, and advanced analytics.

Key Metrics for Success

• Process capability and yield improvement.


• OEE and production throughput improvement.


• Reduction in scrap, deviations, and downtime.


• Successful technology transfers and product launches.


• Engineering project delivery, including schedule, cost, and quality performance.

What Repligen Offers

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 base salary range for this role, based in the United States of America is $140,000-$160,000. Compensation decisions are depende