Director Process Engineering

About

The Director Process Engineering is responsible for process, manufacturing, and sustaining engineering across the filtration network. This role is accountable for building and scaling robust, data-driven production systems that consistently deliver safe, high-quality products at the lowest total cost with minimal variation. Through standardized processes, automation, digital architecture, and continuous improvement, the Director ensures manufacturing operations are efficient, reliable, repeatable, and scalable from technology transfer through full lifecycle sustaining. In close partnership with Operations, Quality, R&D, and OT, this leader drives process capability, equipment performance, product quality, and cost competitiveness while advancing Manufacturing 4.0 and operational excellence across the network.

Key Responsibilities

Leadership & Strategy

• Serve at the senior technical authority, leading engineering decisions, trade-offs, and escalations.
• Align engineering priorities with business objectives through a clear strategy, roadmap, and capability plan.
• Establish engineering standards, best practices, and governance across sites.
• Drive a culture of operational excellence, technical rigor, and continuous improvement.

Engineering

• Own process characterization, validation, and control strategies across manufacturing operations
• Ensure production processes and equipment are capable, efficient, and scalable
• Lead equipment design, selection, installation, and qualification (URS, FAT, SAT, IQ/OQ/PQ)
• Improve performance through automation, workflow optimization, error-proofing (poka-yoke), and data/AI-enabled tools to increase OEE, throughput, and labor productivity
• Ensure design documentation (e.g., BOMs, drawings, technical files) is accurate and controlled
• Support new product introductions and technology transfers into manufacturing
• Ensure engineering solutions meet regulatory, quality, and compliance requirements

Talent Development

• Recruit, develop, and mentor engineering leaders and technical experts
• Build organizational capability in advanced manufacturing, process modeling, and automation
• Foster a high-performance culture focused on accountability, technical excellence, project velocity and execution, continuous improvement, and data-driven decision-making

Qualifications

• Bachelor's or Master's degree in Engineering (Chemical, Mechanical, Industrial, or related discipline)
• 12+ years of engineering and leadership experience in manufacturing environments
• Proven leadership of multidisciplinary engineering teams
• 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 and deliver results
• Strong communication and stakeholder management skills
• SAP and/or Oracle experience

Preferred Experience

• Experience in regulated manufacturing environments (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 (schedule, cost, and quality)

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 salary range for this role, based in the United States of America is $185,000-$270,000. 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.