Process Validation Engineer
Process Validation Engineer
Baxter International
Castlebar, Ireland
You will play a key role in the Quality and Process within our manufacturing, support equipment and processes which are critical to saving and sustaining lives.
Working in the Process Validation Department the successful candidate will be self-driven and motivated person willing to learn and further develop their career as a Process Validation Engineer. The successful candidate will be coached/mentored, and process validation training will be provided.
What will you do?
- Author validation protocols, reports and risk assessments
- Review engineering trials and product development documentation
- Complete Trackwise 8 validation and risk assessments
- Technical approval of validation documentation
- Lead projects to ensure they are executed in a controlled and compliant manner
- Provide status updates on projects
- Presentations and project management
Education and Requirements
- You will have a degree in Science/Engineering or equivalent
- Process validation experience is desirable
- Knowledge of EU GMP and FDA regulatory requirements
- You will have critical thinking and problem-solving skills
- Ability to demonstrate solid decision making and problem-solving abilities.
- Membership of a professional body desirable
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