Our client is seeking a highly motivated Production Operators to join their production team. This is an excellent opportunity to work within a highly regulated GMP manufacturing environment, supporting sterile production operations and ensuring safe, efficient, and compliant manufacturing processes.
The successful candidate will be responsible for operating and monitoring production equipment, maintaining high standards of quality and compliance, supporting continuous improvement initiatives, and ensuring production targets are achieved.
Key Responsibilities
- Operate and monitor production equipment using MES, DCS, and PLC-based systems to ensure optimal equipment performance, reliability, and production output.
- Support sterile manufacturing processes involving equipment such as autoclaves, parts washers, CIP/SIP systems, storage panels, vial washers, depyrogenation tunnels, debaggers, and filling equipment.
- Perform cleanroom cleaning, housekeeping, and materials management activities while maintaining GMP standards.
- Manage sterile and non-sterile equipment flow, including equipment tracking, hold-time management, labelling, inventory control, and status updates using electronic systems and Kanban processes.
- Perform equipment checks, preventative maintenance activities, troubleshooting, and repairs where trained and authorised.
- Support the development, review, and implementation of operational procedures, work instructions, and training documentation.
- Participate in deviation investigations, root cause analysis, corrective actions, and continuous improvement activities.
- Support change controls, Lean manufacturing initiatives, and Kaizen improvement projects.
- Promote a strong safety, quality, and compliance culture within the manufacturing environment.
- Ensure all activities are completed in accordance with cGMP requirements, regulatory standards, and approved procedures.
Skills & Experience Required
- Previous experience in sterile manufacturing, pharmaceutical, biotechnology, or another regulated manufacturing environment preferred.
- Knowledge of sterile filling processes and production equipment.
- Experience working with automated manufacturing systems such as MES, DCS, or PLC-controlled equipment is desirable.
- Understanding of GMP regulations and quality requirements.
- Strong troubleshooting and problem-solving abilities.
- Experience supporting investigations and using root cause analysis tools, including FMEA, Fishbone diagrams, and 5-Why analysis.
- Ability to accurately complete technical documentation, reports, and operational procedures.
- Good IT skills, including Microsoft Office and manufacturing-related computer systems.
- Strong attention to detail with a commitment to quality and compliance.
- Excellent communication skills and the ability to work effectively as part of a team.
- Ability to manage priorities in a fast-paced production environment.
Qualifications & Experience
- Leaving Certificate or equivalent required.
- Technical qualification, apprenticeship, certificate, or diploma in a relevant discipline preferred.
- Previous manufacturing experience, ideally within a GMP-regulated environment.
About the Opportunity
This role offers the opportunity to work with our client in a modern manufacturing environment, supporting advanced sterile production technologies and contributing to a culture of safety, quality, and continuous improvement.
If you have experience in GMP manufacturing and are looking to develop your career within sterile operations, we would like to hear from you.
