Job Summary
The Development Engineer I - Lean and Automation Engineer will identify, assess, develop, and implement continuous improvement and automation solutions to reduce waste and improve manufacturing performance in a regulated Oral Solid Dosage (OSD) environment. This hands-on role focuses on process analysis, manufacturing automation, digitalization, and measurable operational improvements. The engineer will independently drive approved projects from initial analysis and solution development through implementation, training, benefit validation, and sustainment while ensuring compliance with GMP, data integrity, safety, quality, and regulatory requirements.
Key Responsibilities
• Perform process studies, time studies, waste assessments, and bottleneck analyses to identify continuous improvement and automation opportunities.
• Apply Lean Manufacturing, DMAIC, Value Stream Mapping, SMED, Overall Equipment Effectiveness (OEE) improvement, statistical analysis, and root cause analysis techniques.
• Develop evidence-based opportunity assessments that define baseline performance, expected operational and financial benefits, implementation requirements, costs, risks, timelines, and sustainment approaches.
• Present improvement opportunities to the Site Leadership Team (SLT) for prioritization, approval, and sponsorship.
• Own approved projects from analysis through solution development, training, implementation, benefit realization, and sustainment.
• Collaborate with Operations, Finance, Quality, Engineering, and IT/OT teams to execute improvement and automation initiatives.
• Develop and deploy digital and analytics solutions, including Power BI dashboards, Power Automate workflows, and electronic data collection tools, to eliminate non-value-added work.
• Improve OEE, cleaning and changeover/setup times, labor productivity, throughput, and production capacity across manufacturing, laboratories, offices, and warehouse operations.
• Identify opportunities to improve manufacturing automation, operational reliability, and process performance.
• Build practical workflows, dashboards, and data tools to support process optimization and data-driven decision-making.
• Partner with Finance to classify and validate project benefits, maintain consistent benefit reporting, and prevent duplicate reporting or double counting.
• Establish process ownership, standard work, training, operational controls, documentation, and performance tracking before project closure.
• Ensure all improvements comply with GMP, data integrity, safety, quality, change-control, and validation requirements in an FDA-regulated environment.
• Identify opportunities to challenge existing practices, develop practical solutions, and lead implementation while coaching others as needed.
Required Qualifications
• Master's degree in Industrial Engineering, Manufacturing Engineering, Mechanical Engineering, or a related technical discipline.
• 2-3 years of pharmaceutical industry experience, including at least 2 years supporting Oral Solid Dosage (OSD) or tableting/compression operations.
• Demonstrated experience completing waste-reduction or automation projects as the primary executor rather than solely coordinating activities.
• Strong knowledge of Lean Manufacturing, DMAIC, Value Stream Mapping, SMED, OEE improvement, statistical analysis, and root cause analysis.
• Hands-on experience conducting process analysis and identifying opportunities for manufacturing improvement.
• Ability to develop business cases, quantify operational and financial benefits, and build practical workflows, dashboards, or data tools.
• Strong project ownership and the ability to execute cross-functional initiatives within GMP, data integrity, safety, and quality requirements.
• Strong analytical, troubleshooting, critical-thinking, and systems-thinking skills.
• Ability to independently identify improvement opportunities, evaluate potential solutions, and drive approved initiatives through implementation.
• Strong communication, documentation, and collaboration skills.
• Ability to work effectively within an FDA-regulated manufacturing environment while maintaining compliance with applicable quality and safety requirements.
Preferred Qualifications
• Lean Six Sigma Black Belt certification; candidates with Green Belt certification and demonstrated hands-on project delivery experience may also be considered.
• Experience with Power BI, Power Automate, advanced Excel, SQL, SAP, MES/EBR, historian systems, or manufacturing analytics platforms.
• Experience applying modern analytics and AI-enabled tools to improve operational reliability and manufacturing performance.
• Experience in manufacturing automation, robotics, digitalization, or continuous improvement execution.
• Ability to carry approved improvement initiatives through solution development, training, implementation, handoff, and long-term sustainment.
