Niall Kirwan Mengsc

Shift Technical Lead - Downstream Specialist @MSD

Dublin, IE

Guide and mentor a team of bioprocess associates, facilitating training and development initiatives that enhance skills and productivity. • Provide hands-on technical support and direction to address operational challenges and ensure timely resolution of issues. • Troubleshoot technical issues promptly, working closely with quality and engineering teams to identify root causes and implement corrective actions. • Be responsible for all scheduled activities in Downstream Operations as per the standard work plan and real-time schedule, ensuring that production targets are met effectively. Be able to speak to downtime, develop recovery plan and work with finite scheduler on updating production schedule. • Manage the process, supporting area leads as needed ensuring oversight/ guidance for managing process issues. Ensure clear, complete handover to incoming technical lead to ensuring seamless continuity. • Participate and provide guidance to the team in continuous improvement projects aimed at optimizing production efficiency and reducing downtime. • Ensure compliance with Good Manufacturing Practices (GMP) and contribute to internal audits and inspections as required. • Write comprehensive quality deviation reports, analysing the causes and impact of deviations, including human error, and developing corrective and preventive action plans. • Conduct batch record reviews to verify compliance with established standards, ensuring completeness, accuracy, and adherence to regulatory requirements. • Close out Manufacturing Orders (MOs) and Equipment Specifications (ESPs) in the MES system, ensuring all data is accurately reflected and documented. • Oversee safety practices within the production area, ensuring compliance with all safety protocols and regulations. • Promptly report any safety issues and incidents in the Enablon system, maintaining accurate records and following up on corrective actions to ensure they are closed out in a timely manner.