Validation Engineer

Responsibilities:

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.

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. Requirements:

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.