Job SummaryThe Lean and Automation Engineer is a hands-on Continuous Improvement professional responsible for identifying, assessing, building, and implementing solutions that reduce waste and improve manufacturing performance. This role is not a facilitator but an executor who personally drives projects from analysis through solution build, training, implementation, and sustainment. Success is measured by high-quality opportunities identified, approved projects implemented, Finance-validated benefits delivered, and compliant results sustained in a regulated Oral Solid Dosage (OSD) environment.
Key Responsibilities- Conduct process studies, time studies, waste assessments, and bottleneck analysis to identify improvement and automation opportunities.
- Develop evidence-based opportunity assessments covering baseline, expected benefit, cost, risk, timing, and sustainment approach.
- Present opportunities to Site Leadership Team (SLT) for prioritization and sponsorship.
- Own approved projects from analysis through solution build, training, implementation, benefit realization, and sustainment.
- Develop and deploy practical digital and analytics tools (Power BI dashboards, Power Automate workflows, electronic data collection).
- Improve OEE, cleaning/changeover time, labor productivity, throughput, and capacity across manufacturing, labs, offices, and warehouses.
- Partner with Finance to classify and validate benefits consistently and prevent duplicate reporting.
- Establish process ownership, standard work, training, controls, documentation, and performance tracking before project closure.
- Ensure compliance with GMP, data integrity, safety, quality, change-control, and validation requirements in an FDA-regulated environ ment.
Required Qualifications- Master's degree in Industrial, Manufacturing, Mechanical Engineering, or 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 completion of waste-reduction or automation projects as the primary executor.
- Core skills 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 workflows, dashboards, or data tools.
- Strong project ownership and cross-functional execution within GMP, safety, and quality r equirements.
Preferred Qualifications- Lean Six Sigma Black Belt (strong Green Belts with proven delivery considered).
- Experience with Power BI, Power Automate, advanced Excel, SQL, SAP, MES/EBR, and manufacturing analytics platforms.
- Experience applying modern analytics and AI-enabled tools to improve reliability and performance.
- Self-starter with strong analytical, troubleshooting, systems-thinking, communication, and documentation skills.
- Ability to challenge historical practices and carry approved ideas through build, training, implementation, and sustainment.
Certifications (if any)- Lean Six Sigma Black Belt (preferred).
- Green Belt with proven project delivery considered.
