Production Operator – Pharma (Shift)

Summary:
A Production Operator is required for a biopharmaceutical company in Carlow. The successful candidate will perform various production and operations related tasks to aid in the manufacture and reliable supply of product. This is a 4 cycle shift role.

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 operations 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 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 on site.
• May be required to perform other duties as assigned.

Qualifications & Experience:

• Leaving Certificate or equivalent required.
• Apprenticeship, Certificate or Diploma preferred, ideally in a related discipline.
• 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.