The Validation Engineer has a significant impact to the company. There is high criticality level for the work produced. The Validation Engineer is responsible for all respects of the validation process, including: documenting commissioning activities, coordinating F.A.T. and S.A.T. testing, establishing the process and equipment acceptance criteria, and developing and performing qualifications studies to document evidence which provides a high degree of assurance that equipment and processes (including cleaning processes) will consistently produce a product meeting its predetermined specifications and quality attributes. site. The Validation Engineer will be a leader in the Change Control Process by understanding validated systems/processes/equipment and how changes will impact the validated status. The Validation Engineer will play an important role at Akorn, Inc. by working closely with all departments and by being responsible for various projects, which may include, but not limited to the list below:
Include the following. Other duties may be assigned.
- Schedule and plan equipment and process qualification workload to meet approved schedules.
- Handle multiple projects and work independently.
- Design and attend F.A.T. testing at vendor facility, as required.
- Write, execute, and review complex protocols.
- Coordinate validation activities with other departments.
- Operate Thermal mapping Equipment
- Have the ability to problem solve with little oversight, including conducting research to aid in the resolution of issues that arise.
- Train other Validation personnel.
- Purchase supplies and equipment for validation activities
- Administer the site Change Control Program...cont.