Validation Engineer

7 days ago


Singapore ANTER CONSULTING PTE. LTD. Full time

**Key responsibilities:
- Perform Equipment Validation Maintenance Quality Systems review and re-qualification activities to ensure GMP equipment is continuously maintained in a validated state. 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 and train new personnel in these areas
- Demonstrate a thorough understanding of equipment and validation procedures for Installation Qualification (IQ). 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), Laboratory Information Management System (LIMS) and Trackwise system (Change Control, Deviations, CAPA, etc.).
- Perform other duties as assigned

**Key requirements**:

- Bachelor’s Degree in Science or technical discipline
- 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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