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Job Description
Technical Specialist sought for biopharmaceutical plant in Cork to optimize process and ensure quality pharmaceutical products.
We are currently looking for a Technical Specialist to join the Vaccine manufacturing team for a biopharmaceutical plant in Cork. In this role, you will ensure on-going optimization of the process to ensure the continued manufacture and supply of quality pharmaceutical products. **Key Responsibilities:** • Own, plan, and execute continuous improvement projects, leveraging Lean manufacturing principles to enhance processes. • Engage in equipment qualification processes (IQ/OQ to PQ) and draft associated operational Standard Operating Procedures (SOPs). • Lead and contribute to problem-solving initiatives across various IPT areas (e.g., Reliability, Safety, and Qualitysuch as CAPA/QNs). • Manage and close process-related deviations and reports efficiently. • Serve as the first point of contact for frontline technical Environmental, Health, and Safety (EHS) support and provide coaching for operational teams. • Address safety-related issues, including management of change, permits, and risk assessments. • Author, execute, and oversee protocols and reports, ensuring proper approval where necessary. • Uphold the highest standards of quality, compliance, and safety across operations. • Provide ongoing coaching to cross-functional teams, sharing expertise in process engineering and maintenance best practices. • Guarantee product quality by ensuring optimal equipment availability and enhancing team performance through continuous improvement. • Contribute technical, process, and engineering expertise across a wide range of IPT projects, including the introduction of new equipment and processes. • Authorize and approve change controls and MIDAS documents as required. • Troubleshoot and optimize operations within the Vaccine Processing Unit, including areas such as cleaning, sterilization, upstream and downstream processes, lyophilization, buffer preparation, PSA, and material flow. • Lead efforts to maintain compliance with MMD Quality Management Systems (QMS), taking ownership where necessary. • Drive a culture of reliability and continuous improvement through tactical implementation of technical processes and reliability initiatives. • Foster a culture of continuous improvement, integrating digital solutions to enhance operational reliability. **Qualifications & Experience:** • A Level 8 honours degree in a relevant discipline, such as science, engineering, or manufacturing. • 3-5 years of experience in a highly regulated manufacturing environment in a technical or support role. • Strong knowledge and practical experience in applying Lean Six Sigma and Lean methodologies, with a solid understanding of regulatory and validation requirements.