Job Description
JOB OVERVIEW:
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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.
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KEY RESPONSIBILITIES:
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- 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.
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QUALIFICATIONS:
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- 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 cGMP, 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
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WORK ENVIRONMENT:
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On-site, Monday-Friday
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Office and production floor settings
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Fast-paced, compliance-driven environment