Process Engineer - Technical Specialist

AMC22089 Process Engineer/Technical Specialist 11 month contract On site - Cork

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.

This is the ideal role for someone with a technical degree and 3-5 years experience in a technical role within Pharmaceutical manufacturing.

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 Quality—such 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.If you are interested in this posting apply today!

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