repligen
Senior Manager, Engineering
- Compensation
- Not disclosed
- Location
- Remote - Washington
- Work setup
- Remote
- Seniority
- Senior
- Employment
- Not specified
- Experience
- 4+ years
- Category
- Not specified
- Posted
Skills
Must have
- 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.
Nice to have
- 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.
Full description
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.
Responsibilities & Qualifications
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.