Production Operator - Carlow
* Duration: 11 months
* Work setting: Fully on-site position in Carlow
* Salary: Fixed Basic Pay Rate: 18.29 Euro/hourly + Shift Premium 33.33%
* Shift Work: Yes, 24/7 shifts
As part of the IPT team, perform various production and operations related tasks as part of an empowered team to aid in the manufacture and reliable supply of product. Ensure that objectives are effectively achieved, consistent with requirements to ensure compliance, safety and reliable supply to our customers.
Key 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 labeling 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.
* Required to comply with Merck Global Policies, Procedures and Guidelines, regulatory requirements and execute current good manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.
* Work collaboratively to drive a safe and compliant culture in Carlow.
* May be required to perform other duties as assigned.
Experience, Knowledge & Skills required:
* Sterile filling processes and equipment
* Knowledge of regulatory/code requirements to Irish, European and International Codes
* Standards and Practices
* Report, standards, policy writing skills required
* Proficiency in Microsoft Office and job-related computer applications required
* Effective communication and interpersonal skills to interface effectively with all levels of colleagues in a team environment, and with external customers
Qualifications & Education
* Leaving Certificate or equivalent required
* Apprenticeship, Certificate or Diploma preferred, ideally in a related discipline
* Typical Minimum Experience for this Grade/Level
* Would typically have prior related work experience; ideally in a manufacturing, preferably GMP setting.
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