Job Description
**What You Will Achieve**
Reporting to Site Technical Services Lead, this position is responsible for leading the site Validation organization supporting a continuous 24/7 aseptic manufacturing operations. The incumbent will provide strategic and operational leadership for teams responsible for **Process Validation, Cleaning Validation, Aseptic Process Simulations (APS/media fills), Aseptic Process and Equipment Qualifications, Utility Qualifications, Facility and CTU qualifications, Smoke Studies, and Periodic Requalification programs** .
This role serves as the **site Subject Matter Expert (SME) for Validation and Qualification programs** and is the principal point of contact for regulatory agency interactions related to validation strategy, execution, and lifecycle management.
The Senior Manager, Validation is accountable for building, developing, and leading a large, diverse organization of engineering professionals and managers responsible for the dev...
Reporting to Site Technical Services Lead, this position is responsible for leading the site Validation organization supporting a continuous 24/7 aseptic manufacturing operations. The incumbent will provide strategic and operational leadership for teams responsible for **Process Validation, Cleaning Validation, Aseptic Process Simulations (APS/media fills), Aseptic Process and Equipment Qualifications, Utility Qualifications, Facility and CTU qualifications, Smoke Studies, and Periodic Requalification programs** .
This role serves as the **site Subject Matter Expert (SME) for Validation and Qualification programs** and is the principal point of contact for regulatory agency interactions related to validation strategy, execution, and lifecycle management.
The Senior Manager, Validation is accountable for building, developing, and leading a large, diverse organization of engineering professionals and managers responsible for the dev...