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Certified Validation Specialist
3 weeks ago
The Validation Technician will work closely with Automation and Validation Engineers to support validation activities.
- Spearhead the development of IQ, OQ and PQ protocols and reports.
- Coordinate project timelines and resources for completion of a validation project.
Responsibilities:
- Manage customer approval and write comprehensive validation technical reports.
- Chair meetings, take minutes and ensure approver alignment.
- Demonstrate expertise in validations within a Medical Device environment and computer system validation.
- Apply statistical analysis using SPC and Minitab.
- Prioritize tasks and adhere to relevant SOPs.
- Maintain strict adherence to safety and quality policies at all times.
Requirements:
- Hold a third-level qualification in Engineering, Quality or Science.
- Relevant work experience may be considered in lieu of degree qualifications.
- Possess preferred knowledge of ISO 13485 / 21 CFR Part 820 and auditing experience.