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.

• 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.