New opportunity! Production operator in large pharmaceutical company.
You will be responsible for all procedures and processes associated with the Manufacture of Commercial Large-Scale Drug Substance at the manufacturing facility.
Job Responsibilities
· Operate and/or monitor production activities and support equipment, using MES/DCS and PLC based systems, to ensure optimum equipment uptime and target outputs. Equipment will include, yet is not limited to, parts washers, autoclaves, portable tank CIP/SIP/storage panels, Vial Washer, Depyro Tunnel, Debagger and filling machines
· Clean room cleaning, housekeeping and materials management in all production areas while focusing on continuous process improvement using Lean Principles.
· Manage equipment flow, including tracking soiled and clean hold times, proper labelling and inventory management of clean and sterile equipment using Kanbans and automated MES system to set QC status and expiry of sterile equipment.
· Maintain process equipment, completing preventative maintenance and equipment troubleshooting and repairs where qualified to perform tasks.
· Participate effectively in writing/revising/ rolling out accurate operational procedures, training materials for various IPT systems; ensure all work is carried out in line with same. 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. Perform 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.
· May be required to perform other duties as assigned.
Typical Minimum Education
· Leaving Certificate or equivalent required
Typical Minimum Experience for this Grade/Level
· Would typically have prior related work experience; ideally in a manufacturing, preferably GMP setting.
This role is based on shift pattern of 24/7. This involves 12 hour shifts on days and nights, with a 33.33% shift allowance.