Operations Continuous Improvement Associate PPP

Operations Continuous Improvement Associate PPP NA, Gx BER, Ohio

$24.35/hr

• 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, contributing to improved SQDC performance and overall equipment effectiveness (OEE) in primary plastic packaging production.

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

• 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.
• Assist 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.

• 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.

• 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.

• 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.
• Assist with documentation updates, change control processes, and operational audit readiness.
• Participate in 6S and operational audits and support continuous improvement initiatives.

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

• High school diploma or GED required, Associate degree in Manufacturing, Engineering Technology, Industrial Technology, or related field preferred.
• 1–3 years of experience in a manufacturing environment.
• 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.
• Understanding of production performance metrics (OEE, scrap, downtime, yield) preferred.
• Exposure to continuous improvement or structured problem-solving methodologies preferred.
• Ability to read and interpret SOPs, batch records, and technical/controlled documentation.
• 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.
• 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.
• Ability to speak, read, and write English.
• Ability to obtain and maintain a mobile equipment license.