We’re currently recruiting for an exciting opportunity with a Biopharmaceutical organization based in Carlow. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Duties

• Collaboration with other departments and our out-sourced partners to ensure the successful delivery of the Facility and Utility Support function in the safest, most time efficient and cost-effective manner.
• Maintain Facility and Utility Support services in the context of retaining a permanent inspection readiness state for the site.
• Support continuous improvement by active participation in projects, system failure studies and incident investigations using recognised methodologies such as 8SPS, RCA etc.
• Support the development and execution of Change Control related to the Engineering function.
• Participate in and contribute to Lean measures such as Gemba and Kaizen events.
• 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, ensuring consideration of the impact on GMP and compliance and decisions made.
• Accountable for compliance via documentation completion, risk assessments, closing out corrective actions, participate in audits and inspections and proactively highlighting any issues around compliance.
• Escalate issues in a timely manner to relevant onsite stakeholders and support the resolution of any such issues.
• Development of new and review and update of existing SOPs.
• Support site Reliability and Calibration improvement programs.
• Collaborate closely with cross functional teams to ensure project activity is supported through inspection and safety walks.
• Work collaboratively to drive a safe and compliant culture in Carlow.

• Bachelor’s Degree or higher preferred; ideally in an Engineering, Science or other technical discipline
• Lean Six Sigma Methodology experience desired with Green Belt preferred.
• Demonstrated ability to deliver on objectives with limited oversight.
• Experience within Facilities and Utilities support areas in a GMP manufacturing environment and have a proven track record in identifying and delivering improvement projects.
• Proven record of management of change in a commercial site.