Senior Manager, Engineering

RepliGen Corporation•Washington, DC

1d•$140,000 - $160,000•Onsite

About The Position

The Senior Manager, Process and Manufacturing Engineering leads process, manufacturing, and sustaining engineering activities, ensuring operations are efficient, reliable, repeatable, and scalable from technology transfer through the full product lifecycle. In partnership with Manufacturing, Quality, R&D, and OT, this leader advances process capability, equipment performance, product quality, productivity, Manufacturing 4.0, and operational excellence. The position is onsite in Bothell, Washington. The role provides technical direction and translates operational priorities into engineering plans, roadmaps, standards, and capability improvements. It leads process characterization, validation, control strategy development, equipment lifecycle activities, performance improvements, engineering documentation, and engineering support for new product introductions, scale-up, and technology transfers. It also manages and develops engineering staff and technical experts, building capabilities in advanced manufacturing, process modeling, automation, problem solving, and statistical methods. The role is expected to model the company's Leadership Behaviors: Integrity & Compliance, Customer Focus, Collaboration, Courage, Team Empowerment, and Accountability & Results. The estimated U.S. base salary range is $140,000–$160,000. Compensation decisions depend on factors including qualifications, location, internal equity, and market data. Employees are eligible for a variable cash program (bonus or commission), and eligible roles may receive equity. Benefits include paid time off, health, dental and vision coverage, retirement benefits, and flexible spending accounts.

Requirements

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

Nice To Haves

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.

Responsibilities

Provide senior technical leadership and direction for Process and Manufacturing Engineering, supporting sound decisions, engineering trade-offs, and escalations.
Translate business and operational priorities into engineering plans, project roadmaps, and capability improvements aligned with organizational objectives.
Implement and maintain engineering standards, best practices, and governance across supported sites.
Promote operational excellence, technical rigor, disciplined execution, continuous improvement, and proactive problem-solving.
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, including URS, FAT, SAT, IQ/OQ/PQ.
Improve performance through automation, workflow optimization, error-proofing, and data- or AI-enabled tools to increase OEE, throughput, yield, and labor productivity.
Ensure engineering and design documentation—including 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 across functions and sites.
Ensure engineering solutions meet regulatory, quality, safety, and compliance requirements while balancing business needs and risk.
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.
Deliver improvements in process capability and yield, OEE and throughput, scrap, deviations and downtime; support successful transfers and launches; and deliver engineering projects to schedule, cost, and quality expectations.