Job Overview
* We are seeking a Cleaning Validation Engineer to develop and implement cleaning strategies for CIP and COP systems.
Main Responsibilities:
1. Develop and implement cleaning strategies for Clean in Place (CIP) and Clean Out of Place (COP) systems.
2. Lead cleaning validation projects for media, buffer, upstream, and downstream equipment trains.
3. Closely collaborate with colleagues within the Process Engineering and Validation team and cross-functional departments (QA, Manufacturing, Automation, and QC).
4. Author and review cleaning risk assessments, technical protocols, and reports as required.
5. Ensure compliance with EudraLex GMP guidelines.
6. Prioritize cleaning validation activities in line with project schedules.
7. Implement product changeover assessments.
8. Identify requirements for laboratory studies/trials to support cleaning validation activities and consult closely with manufacturing/QC to oversee study design and execution.
9. Identify and implement improvements where feasible to cleaning processes.
10. Lead the execution of cleaning trials and studies on the manufacturing floor at commercial scale.
11. Provide on-floor support for troubleshooting cleaning-related issues and lead investigations into Cleaning Validation deviations.
12. Serve as a subject-matter expert on cleaning validation activities during regulatory agency inspections.
About You
* You will be responsible for leading and executing cleaning validation activities.
* Excellent communication skills are essential for effective collaboration with various teams.
* A strong understanding of EudraLex GMP guidelines is necessary for ensuring compliance.