What are the responsibilities and job description for the Validation Engineer- 238849 position at Medix?
Scope of Role & Responsibilities :
The Senior Validation Engineer, working under the direction of the Project and Validation Managers, will be responsible for the following :
- Draft, lead reviews, and approve Engineering Commissioning protocols (FAT, SAT, etc.) and validation protocols (IOQ and PQ) to support new manufacturing line installation.
- Support the execution of IOQ and PQ protocols.
- Expertise in equipment validation and Computer System Validation.
- Manage, track, and lead closure of discrepancies and deviations in executed validation protocols.
- Draft, lead reviews, and approve validation summary reports.
- Support vendor activities on-site during installation, commissioning, SAT, and pre-IOQ protocol executions.
- Develop and execute validation protocols.
- Participate in project team meetings.
- Provide periodic progress reports and status updates to Project and Validation Managers.
- Work with the data integrity team to ensure compliance in validation activities.
- Strong knowledge in writing Validation Documents (e.g., Validation Master Plans) and working knowledge of statistical analysis.
Qualifications :
Soft Skills :
Hands-On Validation Experience With :
