Validation Engineer
3 days ago
**Key responsibilities**:
- Perform Process Validation activities. Schedule own tasks to be performed as well as tasks for other Specialists as determined by the Validation Manager
- Perform change control assessments for GMP equipment and associated validation activities to ensure compliance with regulatory requirements
- Program, organize, and maintain Validation equipment and supplies.
- Demonstrate a thorough understanding of validation procedures for Qualification. Develop validation protocols from Validation plans and engineering documents.
- Provide strong technical expertise when reviewing and approving SOPs, protocols, change controls, deviations
- Perform assigned Quality Systems activities including: Document Management System (DMS), Trackwise system (Change Control, Deviations, CAPA, etc.).
- Perform other duties as assigned
**Key requirements**:
- Bachelor’s Degree in Science or technical discipline
- More than 5 years of experience in validation, preferably in a batch manufacturing environment.
- Strong technical writing skills and ability to document all work in a meticulous, accurate, and timely manner.
- Strong written and oral communication skills and ability to work interdepartmentally with very mínimal supervision in an effective manner to carry out daily duties.
- Understand how to write discrepancies, give a root cause analysis and perform Quality Risk Assessments.
- Strong organizational and time management skills
- Demonstrates ability to prioritize tasks as needed to support the changing business demands.
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