Production Operator

· 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 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.

· May be required to perform other duties as assigned.

Core Competencies

· Technical

· o Sterile filling processes and equipment

· o Knowledge of regulatory/code requirements to Irish, European and International Codes,

· Standards and Practices

· o Report, standards, policy writing skills required

· o Proficiency in Microsoft Office and job related computer applications required

Business

· Effective communication and interpersonal skills to interface effectively with all levels of

· colleagues in a team environment, and with external customers

· Understand the specific responsibilities of all departments as they relate to ones

· own department, understanding the business processes ones department supports

· Customer service

· Self-motivated

· Flexible approach

· Effective time management and multi-tasking skills

· Excellent attention to detail

· Trouble shooting skills

· Goal/results orientated

· Training skills

Leadership:

· Focus on Customers and Patients

· Collaborate

· Act with Candor and Courage

· Make Rapid, Disciplined Decisions

· Drive Results

· Build Talent

· Demonstrate Ethics and Integrity

Typical Minimum 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.