IT Sofware Validation Engineer

• Develops and executes Computer System Validation (CSV) activities for software applications supporting medical device manufacturing and quality systems.
• Creates, reviews, and approves validation documentation including Validation Plans, User Requirements Specifications (URS), Functional Specifications (FS), Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrices, and Validation Reports.
• Validates new software systems, upgrades, enhancements, and customized solutions used in regulated environments.
• Ensures compliance with FDA regulations, including FDA 21 CFR Part 11, and applicable quality system requirements.
• Applies GAMP 5 principles and risk-based approaches throughout the software validation lifecycle.
• Evaluates and validates process interfaces, data integrations, and system customizations to ensure data integrity and system reliability.
• Collaborates with IT, Quality, Engineering, Manufacturing, and Regulatory Affairs teams to define validation requirements.
• Supports audits and regulatory inspections by providing validation evidence and documentation.
• Participates in change management activities and assesses validation impacts resulting from system modifications.
• Ensures validated systems remain compliant throughout their lifecycle through periodic reviews and revalidation activities.
• Identifies and implements continuous improvement opportunities related to validation processes and regulatory compliance.

Qualifications:

• Bachelor's degree in Computer Science, Information Technology, Software Engineering, Biomedical Engineering, or related discipline.
• Minimum 3 years of experience in Computer System Validation (CSV), Software Validation, or IT Validation within Medical Device, Pharmaceutical, or Life Sciences industries.
• Advanced English communication skills, both written and verbal.
• Strong knowledge of FDA regulations, including 21 CFR Part 11.
• Working knowledge of ISO 13485 and GAMP 5 methodologies.
• Experience validating software systems used in regulated environments.
• Experience with software implementation, customization, and process interfaces.
• Experience developing and maintaining medical validation documentation.
• Strong understanding of Software Development Life Cycle (SDLC), risk management, and change control processes.
• Experience with systems such as ERP, MES, PLM, QMS, LIMS, or other regulated applications is preferred.
• Strong analytical, troubleshooting, and problem-solving skills.

• 3+ years of experience performing Computer System Validation (CSV).
• Experience validating software used in medical device environments.
• Knowledge of FDA, ISO 13485, and GAMP 5 requirements.
• Experience with process interfaces, system integrations, and data integrity controls.
• Experience creating and maintaining validation deliverables and compliance documentation.
• Advanced English proficiency.

• Competitive Salary.
• Life & Medical Insurance.
• Christmas Bonus.
• Food Coupons.
• Saving Fund.

KM09

Job Category IT

Required Skills:

Optional Skills:

Flex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. We do not discriminate based on: age, race, religion, color, sex, national origin, marital status, sexual orientation, gender identity, veteran status, disability, pregnancy status, or any other status protected by law. We're happy to provide reasonable accommodations to those with a disability for assistance in the application process. Please email accessibility@flex.com and we'll discuss your specific situation and next steps (NOTE: this email does not accept or consider resumes or applications. This is only for disability assistance. To be considered for a position at Flex, you must complete the application process first).