Lean and Automation Engineer

About the role

This role focuses on identifying and executing process improvement and automation opportunities within pharmaceutical manufacturing operations, specifically supporting Oral Solid Dosage (OSD) or tableting/compression processes. The successful candidate will own projects from analysis through implementation and sustainment, working cross-functionally to drive measurable operational and financial benefits.

Responsibilities

• Personally perform process studies, time studies, waste assessments, and bottleneck analysis to identify improvement and automation opportunities.
• Develop evidence-based opportunity assessments covering the baseline, expected operational and financial benefit, implementation needs, cost, risk, timing, and sustainment approach.
• Present opportunities to the Site Leadership Team (SLT) for prioritization, approval, and sponsorship.
• Own approved projects from analysis through solution build, training, implementation, benefit realization, and sustainment, working with Operations, Finance, Quality, Engineering, and IT/OT as required.
• Develop and deploy practical digital and analytics tools, including Power BI dashboards, Power Automate workflows, and electronic data collection, to eliminate non-value-added work.
• Improve OEE, cleaning and changeover/setup time, labor productivity, throughput, and capacity across manufacturing, laboratories, offices, and warehouse operations.
• Partner with Finance to classify and validate benefits consistently, maintain one agreed view of project value, and prevent duplicate reporting or double counting.
• Establish process ownership, standard work, training, 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.

Qualifications

• Master's degree in industrial, manufacturing, mechanical engineering, or a related technical discipline is required.
• 2-3 years of pharmaceutical industry experience is required, including at least 2 years supporting Oral Solid Dosage (OSD) or tableting/compression operations.
• Demonstrated completion of waste-reduction or automation projects with the candidate as the primary executor, not a coordinator.
• Proficiency in Lean Manufacturing, DMAIC, Value Stream Mapping, SMED, OEE improvement, statistical analysis, Root Cause Analysis, and hands-on process analysis.
• Ability to identify opportunities, develop business cases, quantify benefits, and build practical workflows, dashboards, or data tools.
• Strong project ownership and effective cross-functional execution within GMP, data-integrity, safety, and quality requirements.

Nice to have

• Lean Six Sigma XX Belt. Strong Green Belts with proven hands-on delivery considered.
• Experience applying modern analytics and AI-enabled tools to improve operational reliability and performance.
• Ability to challenge historical practices and carry an approved idea through build, training, implementation, handoff, and sustainment.

Skills

• Power BI
• Power Automate
• Advanced Excel
• SQL
• SAP
• MES/EBR
• Historian or manufacturing analytics platforms
• Lean Manufacturing
• DMAIC
• Value Stream Mapping
• SMED
• OEE improvement
• Statistical analysis
• Root Cause Analysis
• Analytical skills
• Troubleshooting
• Systems-thinking
• Strong verbal and written communication skills
• Documentation
• Compliance

Benefits

• Medical, Dental, and Vision Insurance
• 401(k) Retirement Plan
• Health Savings Account (HSA)
• Disability Insurance (Short-Term and Long-Term)
• Life and AD&D Insurance
• Paid Sick Leave (where required by applicable state or local law)
• Supplemental Insurance Plans
• Identity Theft Protection
• Pet Insurance
• Employee Wellness Programs
• Employee Assistance Program (EAP)
• Career Growth and Professional Development Opportunities

This response is AI-generated, for reference only.