Director, Engineering
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.
- 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
- 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
- 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
- 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
- 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)
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