Operations Continuous Improvement Associate PPP NA, Gx BER, Ohio $24.35/hr Main tasks

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.

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.
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.

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.
Assist with 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.
Assist in training operators on new or improved processes and standard work procedures.
Perform additional duties as required to support changing business needs.

Qualifications

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

About Gerresheimer Gerresheimer is an innovative system and solution provider and global partner for the pharma, biotech and cosmetics industries. The company offers a comprehensive portfolio of pharmaceutical packaging, drug delivery systems, medical devices and digital solutions. Gerresheimer ensures the safe delivery and reliable administration of drugs to the patient. With around 13,400 employees and over 40 production sites in 16 countries in Europe, America and Asia, Gerresheimer has a global presence and produces locally for regional markets ****** Über Gerresheimer Gerresheimer ist als innovativer System- und Lösungsanbieter der globale Partner der Pharma-, Biotech- und Kosmetikindustrie. Das Unternehmen bietet ein umfassendes Portfolio an pharmazeutischen Primärverpackungen, Verabreichungssystemen für Medikamente und digitalen Lösungen. Gerresheimer sorgt dafür, dass Medikamente sicher zum Patienten gelangen und zuverlässig verabreicht werden können. Mit rund 13.400 Mitarbeitenden, und über 40 Produktions-standorten in 16 Ländern in Europa, Amerika und Asien ist Gerresheimer global präsent und produziert vor Ort für die regionalen Märkte

Operations Continuous Improvement Associate PPP

Operations Continuous Improvement Associate PPP

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