Operations Continuous Improvement Associate PPP

Operations Continuous Improvement (CI) Overview

The Operations Continuous Improvement (CI) Associate supports daily manufacturing operations while driving process improvements, reducing waste, and enhancing efficiency, quality, and safety in a GMP-regulated pharmaceutical packaging environment.

Area of Responsibility

Overall responsible for all activities within PPP NA (Gx Berlin, Ohio)

Operational Support

• Work directly on the production floor to support manufacturing teams in maintaining stable, efficient operations.
• Monitor production processes to identify real-time inefficiencies, defects, downtime causes, and performance gaps.
• Aid operators and supervisors in troubleshooting process and equipment issues.
• Ensure adherence to standard work, batch records, and Good Manufacturing Practices (GMP) procedures.
• Follow all safety policies and procedures, including proper use of required PPE.
• Safely perform physical tasks, including lifting up to 56 lbs and moving up to 200 lbs with appropriate assistance or equipment.

Continuous Improvement Execution

• Support Lean Manufacturing initiatives including 6S, Kaizen events, SMED, and standardized work implementation.
• Identify and eliminate waste (motion, waiting time, scrap, overproduction, and rework).
• Collect, analyze, and interpret production data to identify trends, losses, and improvement opportunities.
• Participate in daily tier meetings and Gemba walks to support performance tracking and improvement actions.
• Assist in implementing corrective and preventive actions (CAPA) related to operational issues.

Process Optimization

• Support improvement projects aimed at increasing OEE and overall line efficiency.
• Assist with trial runs, process adjustments, and validation of operational improvements.
• Collaborate with Maintenance to improve equipment reliability and reduce unplanned downtime.
• Analyze production performance data (scrap rates, cycle times, downtime, yield loss) to support improvement efforts.

Quality & GMP Compliance

• Ensure all activities comply with FDA regulations (21 CFR Part 210/211) and internal quality systems.
• Support investigations of deviations, non-conformances, and production quality issues.
• Maintain strict adherence to cleanroom and contamination control requirements where applicable.
• Absorb documentation updates, change control processes, and operational audit readiness.
• Participate in 6S and operational audits and support continuous improvement initiatives.

Cross-Functional Collaboration

• Work closely with Production, Quality Assurance, Technical, Engineering, and Supply Chain teams.
• Provide feedback from the production floor to support engineering and CI initiatives.
• Absorb training operators on new or improved processes and standard work procedures.
• Perform additional duties as required to support changing business needs.

Qualifications

• A high school diploma or GED is required.
• An Associate degree in Manufacturing, Engineering Technology, Industrial Technology, or a related field is preferred.
• One to three years of experience in a manufacturing environment.
• A basic understanding of GMP (Good Manufacturing Practices) and regulated production environments.
• Familiarity with Lean Manufacturing principles such as 6S, Kaizen, waste reduction, and standardized work.
• An understanding of production performance metrics (OEE, scrap, downtime, yield) is preferred.
• Exposure to continuous improvement or structured problem-solving methodologies is preferred.
• Strong analytical, problem-solving, and attention-to-detail skills.
• Proficiency in Microsoft Office applications (Excel, Word, PowerPoint).
• Strong communication and teamwork skills in a production environment.
• The ability to work in a fast-paced, regulated manufacturing setting with strict adherence to safety and quality standards.
• Strong organizational skills and ability to maintain accuracy in documentation and tasks.
• The ability to speak, read, and write English.
• The ability to obtain and maintain a mobile equipment license.