About the job
- Proven experience in Cleaning Validation is essential.
- In-depth knowledge of a Risk-Based Approach to Commissioning and Qualification practices.
- Skilled in planning and integrating Commissioning and Qualification activities specifically in medical device manufacturing, with a preference for Class II products.
- Expertise in Risk Management practices including Assessments, Functional Risk Documents, and pFMEA.
- Experience with equipment qualification and process validation is required.
- Familiarity with Computerized System Validation (PLC, HMI, etc.) is a must.
- Understanding of 21 CFR Part 11 requirements and the ability to incorporate these into an effective testing strategy.
- Assist in investigating deviations and resolving issues encountered during field activities.
