At Flex, we welcome people of all backgrounds. Our employees thrive here by living our values: we support each other as we strive to find a better way, we move fast with discipline and purpose, and we do the right thing always.Through a respectful, inclusive and collaborative culture, a career at Flex offers the opportunity to make a difference, invest in your career growth and join our purpose - to make great products that create value and improve people's lives.Job SummaryTo support our extraordinary teams who build great products and contribute to our growth, we're looking to add a/an Validation Engineer located in Juarez, South Site, Mexico reporting to the Information Technology Manager, the Validation Engineer role involves.What a typical day looks like:- Define, design, implement Validated systems in compliance with FDA specifications and Change control-- Ensure knowledge pertaining to new implementations and technologies are adequately shared with the team.- Ensure adequate monitoring and controls are in place to ensure the stability of the solutions.- Establish clear communication channels and ensure proper feedback mechanisms are in place with customers, peers and cross functional teams.- Ensure proper retention policies are in place to ensure systems are validated- Propose system enhancements (software and hardware updates) that will improve the performance and reliability of the system.- Make final decisions on administrative or operational matters and ensure operations' effective achievement of objectives.- Establish and assure adherence to budgets, schedules, work plans and performance requirements.The experience we're looking to add to our team:- Intermediate English- Typically requires a bachelor degree or equivalent work experience-- Must have in-depth knowledge of FDA Part 11 and Part 820 regulation- Outstanding Oral and Written communication skills with a high attention to detail- Software Validation and compliance to 21 CFR Part 11, ERES, Part 820, and GAMP 5.- Computerized Systems Validations- Working knowledge of GAMP5, 21 CFR Part 11, ERES, 21 CFR part 820, ANSI/AAMI/IEC 62304 Medical Device Software and System Development Life Cycle Process.- Software Quality Engineer working with Validation Engineers to complete the validation documents and review and sign the IQ, OQ, PQ Protocols and Reports.What you'll receive for the great work you provide:- Pantry vouchers- Saving Fund- Christmas bonus- Holiday bonus- Medical Insurance- Life InsuranceCP68Job CategoryIT**Required Skills**:Optional Skills:.
