Operational Excellence Engineer II

Responsibilities

• Identify and execute opportunities for cost savings, increased throughput, and workflow optimization within pharmaceutical manufacturing.
• Conduct in-depth workflow analyses, time studies, and data collection to standardize GMP-regulated processes.
• Apply Lean and Six Sigma methodologies, including value stream mapping, 5S, and cycle time analysis, to reduce waste and deviations.
• Develop and present detailed productivity reports, KPIs, and dashboards to support leadership decision-making.
• Facilitate cross-functional problem-solving workshops and Kaizen events to support root cause investigations and CAPA implementation.
• Design and enhance work area layouts to improve ergonomics and operational efficiency.
• Lead and mentor multiple improvement projects using the DMAIC process.
• Assist in the creation and revision of GMP documentation, including SOPs and work instructions.

Requirements

• B.S. in Engineering, Operations Management, Industrial/Manufacturing Engineering, or a related field.
• 3+ years of experience leading process improvement and operational excellence initiatives in a GMP-regulated manufacturing environment.
• Strong understanding and application of Lean and Six Sigma methodologies.
• Proficiency in MS Office (Word, Excel, PowerPoint) and Visio.
• Experience with 2D/3D CAD (AutoCAD, SolidWorks) and statistical analysis software (Minitab, JMP).
• Demonstrated project management skills and the ability to work independently.

Preferred Qualifications

• Experience in aseptic or sterile manufacturing operations.
• Lean/Six Sigma Green Belt or Black Belt certifications.
• Experience with low-volume, high-changeover manufacturing in pharmaceutical or biologics environments.

Benefits

• Annual pay range of $90,000 - $100,000 depending on experience.
• Bonus eligibility.
• Comprehensive benefits package.

About the Company

Tolmar is a pharmaceutical company dedicated to improving lives through high-quality products. We operate with a culture of continuous improvement, ethical conduct, and accountability, placing people at the heart of our mission to support patient well-being.