Process Improvement Engineer with pharmaceutical manufacturing experience, specializing in Lean methodologies, root cause analysis, and process optimization. Proven track record in leading improvement projects, integrating new technologies, enhancing quality, efficiency, and compliance. Strong cross-functional collaborator with a hands-on, solution-focused approach.
Lead cross-functional A3 improvement projects focused on increasing throughput, reducing waste, and enhancing safety, and product quality across manufacturing lines.
Standardize work instructions (WIs) and SOPs across key production areas, ensuring alignment with GMP and regulatory compliance.
Drive equipment commissioning and technology integration projects in collaboration with project engineers and validation teams.
Conduct structured problem-solving (5 Whys, Fishbone) to resolve recurring manufacturing issues and remove process barriers.
Manage recipe systems and support product design scale-up, ensuring accurate process control and documentation.
Execute safety and quality risk assessments and document system changes through formal change control processes.
Collaborate closely with operations, QA, engineering, and project teams to drive end-to-end improvements.
Executed data-driven improvement projects using Lean and Six Sigma methodologies to optimize product quality, reduce material waste, and drive manufacturing efficiency gains.
Lead improvement projects. Facilitated root cause investigations and continuous improvement workshops using tools such as PDCA, 5 Whys, and Fishbone diagrams.
Led the rollout of World Class Operations (WCO) initiatives, aligning site practices with global operational excellence standards.
Developed and implemented tiered daily accountability meetings and visual SQDCP boards to drive performance transparency and align with the company strategy.
Delivered Rapid Problem Solving (RPS) and Focused Problem Solving (FPS) training sessions to operators, team leaders, and support staff, enhancing site-wide problem-solving capability.
Set up, operated, and optimized encapsulation machinery to ensure consistent product quality and output within GMP standards.
Conducted first-level troubleshooting and coordinated with maintenance teams to minimize equipment downtime.
Performed in-process quality testing and documented results in line with regulatory and internal requirements.
Served as the EHS representative, supporting safety initiatives, risk assessments, and compliance with site safety procedures.
Collaborated with the Innovation and Development team during new product development (NPD) trials, providing technical input, and operational support.
Partnered with the Continuous Improvement team to support and implement process optimization projects at the line level.
Maintained accurate documentation of operational activities, changeovers, and process deviations for traceability and audit readiness.