Biotechnology Process Validation Specialist
5 days ago
About the Job
We are currently looking for a qualified Biotechnology Process Validation Specialist to join our team in Carlow. As a key member of our operations team, you will be responsible for providing technical support and guidance on process simulation development and execution.
Your Key Responsibilities
- Design and execute process simulations studies in support of new product introduction and ongoing manufacturing support.
- Provide technical input into quality notification by authorizing/reviewing/approving Process Simulation related investigations.
- Author and review qualification/validation documentation and studies in line with the standard approval process.
- Perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis.
- Support continuous improvement through Lean Six Sigma methodologies.
Your Requirements
- Bachelor's Degree or higher preferred; ideally in a Science, Engineering or other Technical Discipline.
- 3 - 5 year's operations experience in a sterile manufacturing environment, preferably with Aseptic Process Simulations execution.
- Demonstrated ability to coach and lead change.
- Strong Knowledge of Sterile Manufacturing Processes with a focus on delivery and results within highly regulated controlled environment.
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