Validation Engineer

• 5+
• Tempe, AZ.

Job Description

POSITION RESPONSIBILITIES:
 Experience validating non product software (example- development, testing, mechanical) in
healthcare domain ensuring compliance with FDA guidelines.
 Conduct risk assessments to identify and prioritize validation activities.
 Create and maintain essential validation documentation, including User Requirements
Specifications (URS), Validation Plans, Test Protocols (IQ, OQ, PQ), and Final Validation Reports
 Execute IQ, OQ, and PQ activities to ensure tools function as intended in the operational
environment.
 Work closely with cross-functional teams, including IT, quality assurance, and regulatory affairs,
to align on validation strategies and ensure compliance
 In-depth understanding of FDA guidance related to non-product software validation (e.g., 21
CFR Part 820) and familiarity with risk management principles and practices.
 Familiarity with GAMP 5, Computer Software Assurance for Production and Quality System
Software

DESIRED/PREFERRED QUALIFICATIONS:
 Bachelor’s / master’s degree in computer science or equivalent.
 Experience in software validation, in regulated environments with proven experience with tool
validation processes.
 Experience with Semiconductor manufacturing processes is preferred.
 Strong analytical and problem-solving skills.
 Excellent communication and documentation abilities.
 Able to work in cross-functional and cross-cultural global teams
 Knowledge of different software testing methodologies
 Proficient in validation tools and methodologies.
 Ability to work independently and collaboratively in a fast-paced environment.