Development Engineer I

Job Title: Lean and Automation Engineer
Location: Davie, FL
Duration: 6 Months

Shift Schedule: Standard working hours of 8:00 AM to 5:00 PM

Education:

• Master's degree in industrial, manufacturing, mechanical engineering, or a related technical discipline is required.

Experience:

• 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.

Required Core Essential Skill Set:

• 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

Preferred Skills:
Lean Six Sigma Black Belt; strong . Belts with proven hands-on delivery considered. A practical project example will be discussed on site.

• Power BI, Power Automate, advanced Excel, SQL, SAP, MES/EBR, and historian or manufacturing analytics platforms.
• Experience applying modern analytics and AI-enabled tools to improve operational reliability and performance.
• Self-starter with strong analytical, troubleshooting, systems-thinking, communication, documentation, and compliance skills.
• Ability to challenge historical practices and carry an approved idea through build, training, implementation, handoff, and sustainment.

Job Summary
We're looking for a hands-on Continuous Improvement & Automation Engineer who identifies, assesses, builds, and implements solutions that reduce waste and improve manufacturing performance - not a facilitator or meeting coordinator. You will personally bring approved projects to life through analysis, solution development, automation build, training, implementation, and sustainment. Success is measured by high-quality opportunities identified, approved projects implemented, Finance-validated benefits delivered, and compliant results sustained. This role offers meaningful ownership and impact in a regulated Oral Solid Dosage environment.

Key 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; project priority and resource commitment remain with the SLT.
• 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.