Job Description
Production Operators play a vital role in our IPT team, responsible for executing various production and operations-related tasks to ensure the manufacture and reliable supply of products. Their primary goal is to achieve objectives effectively, aligning with company requirements to maintain compliance, safety, and reliable supply to customers.
Duties:
* Operate and/or monitor production activities and support equipment, utilizing MES/DCS and PLC-based systems, to guarantee optimum equipment uptime and target outputs. This includes equipment such as parts washers, autoclaves, portable tank CIP/SIP/storage panels, Vial Washer, Depyro Tunnel, Debagger, and filling machines.
* Maintain cleanliness and organization in all production areas while focusing on continuous process improvement using Lean Principles.
* Manage equipment flow, including tracking soiled and clean hold times, proper labeling, and inventory management of clean and sterile equipment using Kanbans and automated MES systems to set QC status and expiry of sterile equipment.
* Perform routine maintenance on process equipment, completing preventative maintenance and equipment troubleshooting and repairs where qualified to perform tasks.
* Collaborate in writing/revising/rolling out accurate operational procedures, training materials for various IPT systems; ensure all work is carried out in line with these standards. Support continuous improvement by active participation in investigations and investigation reports, execution/development of change control, and contribution to Kaizen events and projects as appropriate. Conduct root cause analysis, using standard tools and methods, to resolve system issues (e.g., FMEA, Fishbone diagrams, 5 why's etc.); implement subsequent corrective action through the change management system.
Required Skills and Qualifications
Education: Leaving Certificate, Apprenticeship, or Diploma preferred, ideally in a related field. Prior related work experience, ideally in manufacturing, preferably GMP settings, is beneficial.
Experience: Sterile filling processes and equipment experience are highly desirable.