Type:

full-time

Job Description:

JOB OVERVIEW

The Continuous Improvement Engineer is a data-driven, solutions-oriented professional dedicated to advancing operational excellence within pharmaceutical packaging operations. This role plays a critical part in identifying inefficiencies, optimizing workflows, and ensuring strict adherence to cGMP and FDA regulatory standards. The ideal candidate combines strong analytical capabilities with hands-on experience in Lean methodologies, including 5S and visual management, and thrives in cross-functional environments to deliver measurable improvements in productivity, quality, safety, and customer satisfaction.

KEY RESPONSIBILITIES

Lead and support continuous improvement initiatives across packaging operations using Lean, Six Sigma, Kaizen, and 5S methodologies. Drive 5S implementation and sustainment efforts, including workplace organization, standardization, and visual controls to improve efficiency and safety. Develop and implement visual management systems (e.g., dashboards, production boards, status indicators) to enhance communication and performance tracking. Analyze production workflows, equipment performance, and material flow to identify bottlenecks, waste, and improvement opportunities. Facilitate value stream mapping (VSM) and process mapping activities to optimize end-to-end operations. Collaborate with cross-functional teams including Quality, Production, Engineering, Maintenance, and Supply Chain to implement sustainable solutions. Apply root cause analysis tools (e.g., 5 Whys, Fishbone/Ishikawa diagrams) and lead corrective and preventive actions (CAPA) for recurring issues. Develop, track, and report key performance indicators (KPIs) to measure the effectiveness of improvement initiatives. Support standard work development, line balancing, and process standardization to ensure consistency and repeatability. Identify and implement waste reduction initiatives (e.g., scrap, rework, downtime, changeover time) using Lean principles. Lead SMED (Single-Minute Exchange of Dies) and setup reduction projects to improve equipment uptime and flexibility. Promote a culture of continuous improvement through training, coaching, and employee engagement at all levels. Ensure all improvement activities comply with cGMP, FDA, and other regulatory requirements. Prepare and present project updates, metrics, and performance reports to senior leadership.

QUALIFICATIONS

Bachelor's degree in Industrial Engineering, Manufacturing, or a related field preferred; equivalent experience will be considered. 5-7 years of experience in continuous improvement or process engineering, preferably in pharmaceutical or regulated manufacturing; recent graduates with relevant internship or co-op experience are encouraged to apply. Certification in Lean Six Sigma (Green Belt or higher preferred) Strong understanding of c

GMP, FDA

regulations, and pharmaceutical packaging processes Proficiency in data analysis tools (Excel, Minitab, Power BI) and project management software Excellent problem-solving, communication, and facilitation skills Ability to influence and lead cross-functional teams Project management skills/experience

WORK ENVIRONMENT

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