-
Job Description
Technical Specialist sought for 11-month contract in Cork to optimize vaccine manufacturing processes 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 be responsible for ensuring the continued manufacture and supply of quality pharmaceutical products by optimizing processes.
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).
- 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.
Skills:
- Process Engineering
- Lean six sigma
- Vaccines