We are seeking an experienced Process Engineer to join our team at Life Science Recruitment. This is a fantastic opportunity for anyone looking to work with a leading multinational organization.
The successful candidate will have the following responsibilities:
* Design, author, review, approve and execute qualification/validation documentation and process development studies in line with standard approval processes.
* Develop and implement change controls.
* Contribute to Kaizen events as required.
* Provide technical input into quality notifications by authoring, reviewing and approving investigations.
* Execute equipment/qualification validation programs, including re-qualification and re-validation.
* Support continuous improvement through Lean Six Sigma methodologies.
* Analyze system failures and substandard performance using standard tools and methods to resolve machine and system issues.
* Represent the technical engineering function in internal discussions and represent Operations Carlow at global technical forums.
* Ensure compliance with Global Policies, Procedures and Guidelines, regulatory requirements and current Good Manufacturing Practices (cGMP) in daily activities and all applicable job functions.
* Work collaboratively to drive a safe and compliant culture.
Requirements:
* Bachelor's Degree or higher in a Science, Engineering or Technical discipline preferred.
* Minimum 3 years of experience in manufacturing, preferably GMP Setting.
* Demonstratable experience leading technical related projects.
* Evidence of continuous professional development desirable.
* Knowledge of process monitoring systems, automation systems and operational intelligence & data systems within a GMP manufacturing environment beneficial but not necessary.