Valuation Engineer Position
This is an excellent opportunity to join a leading multinational in the Biopharmaceutical industry based in Carlow.
* Design, author, review, approve and execute qualification/validation documentation and cycle development studies in line with the standard approval process.
* Develop and execute change controls to ensure compliance and efficiency.
* Resolve technical issues during study execution and engage with production, maintenance and quality representatives as needed.
* Provide technical input into quality notifications and investigations, and perform root cause analysis of system failures.
* Support continuous improvement through Lean Six Sigma methodologies and serve as validation representative for cross-functional projects.
* Ensure compliance with Global Policies, Procedures and Guidelines, regulatory requirements and current Good Manufacturing Practices (cGMP).
* Support regulatory audits and submissions as required.
Key Requirements
* Experience in cleaning validation, including CD & PQ of mobile vessels and parts washers, recipe development & optimisation, cleaning verification, cleanability and recovery studies.
* Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification.
* Exception/Deviation Management and Change Control experience.
* Demonstratable experience of leading technical related projects.
Essential Skills
* Knowledge of process monitoring systems, automation systems and operational intelligence & data systems within a GMP manufacturing environment.
* Equipment and process validation expertise.
* Familiarity with Sterile Fill-Finish processes and equipment.