Validation Engineer - Katalyst Healthcares & Life Sciences

Job Description
The Quality Assurance (QA) Validation Lead is responsible for the Computer System Validation (CSV) and change control processes in a GxP-regulated environment. The QA Validation Lead provides compliance guidance to InClin business leadership and CSV System stakeholders.


Requirements

• Strong understanding of regulations and guidance related to Computer System Validation principles and Quality Management Systems (21CFR Part 11, GAMP- 5, EU Annex 11 and other relevant regulations).
• Bachelor's degree or equivalent experience in computer science, information technology, or a related field.
• Minimum of 5 year of related experience in a cGMP facility, including experience with FDA regulations, medical, drug and device products.
• Installation, Operational and Performance Qualification protocol generation and execution experience
• Excellent technical writing and verbal communication skills.
• Good communication skills and leadership skills.
• Knowledge of cGMP Process and Product Validation requirements and techniques.
• High degree of proficiency in Microsoft Office Suite and Smartsheet
• Detail-oriented with a strong analytical mindset and problem-solving capabilities
• Excellent project management skills, with the ability to lead cross-functional teams and manage multiple projects simultaneously