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A career at Flex offers the opportunity to make a difference and invest in your growth in a respectful, inclusive, and collaborative environment. If you are excited about a role but don't meet every bullet point, we encourage you to apply and join us to create the extraordinary.
Job SummarySummary:To support our extraordinary teams who build great products and contribute to our growth, we're looking to add an
IT Software Validation Engineer located in
Aguascalientes , Mexico.
Responsibilities:- 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.
The experience we're looking to add to our team:- 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.
What you'll receive for the great work you provide:- Competitive Salary.
- Life & Medical Insurance.
- Christmas Bonus.
- Food Coupons.
- Saving Fund.
KM09
Job CategoryIT
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).
