{"id":3329595,"url":"https://alion.io/job/flex-it-sofware-validation-engineer","title":"IT Sofware Validation Engineer","company":{"id":1845316,"name":"Flex","domain":"flex.com","url":"https://alion.io/company/flex-com","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":83,"open_postings":106,"ghost_share":0,"stale_share":0.66,"repost_share":0.009,"time_to_fill_p50_days":26,"computed_at":"2026-10-28T05:59:10Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"middle","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"explicit","locations":["Aguascalientes, Mexico"],"countries":["MX"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":24000,"max_usd":55000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":10},"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 11","optional":false},{"name":"ISO 13485","optional":false},{"name":"LIMS","optional":false}],"status":"live","first_seen_at":"2026-10-26T00:00:00Z","employer_posted_date":"2026-10-26","last_verified_at":"2026-10-28T07:09:50Z","board_verified":true,"closed_at":null,"days_open":2,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":2},"description":"Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world.\nA 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.\nJob Summary\n\nSummary:\nTo 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.\nResponsibilities:\nDevelops and executes Computer System Validation (CSV) activities for software applications supporting medical device manufacturing and quality systems.\nCreates, 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.\nValidates new software systems, upgrades, enhancements, and customized solutions used in regulated environments.\nEnsures compliance with FDA regulations, including FDA 21 CFR Part 11, and applicable quality system requirements.\nApplies GAMP 5 principles and risk-based approaches throughout the software validation lifecycle.\nEvaluates and validates process interfaces, data integrations, and system customizations to ensure data integrity and system reliability.\nCollaborates with IT, Quality, Engineering, Manufacturing, and Regulatory Affairs teams to define validation requirements.\nSupports audits and regulatory inspections by providing validation evidence and documentation.\nParticipates in change management activities and assesses validation impacts resulting from system modifications.\nEnsures validated systems remain compliant throughout their lifecycle through periodic reviews and revalidation activities.\nIdentifies and implements continuous improvement opportunities related to validation processes and regulatory compliance.\nQualifications:\nBachelor's degree in Computer Science, Information Technology, Software Engineering, Biomedical Engineering, or related discipline.\nMinimum 3 years of experience in Computer System Validation (CSV), Software Validation, or IT Validation within Medical Device, Pharmaceutical, or Life Sciences industries.\nAdvanced English communication skills, both written and verbal.\nStrong knowledge of FDA regulations, including 21 CFR Part 11.\nWorking knowledge of ISO 13485 and GAMP 5 methodologies.\nExperience validating software systems used in regulated environments.\nExperience with software implementation, customization, and process interfaces.\nExperience developing and maintaining medical validation documentation.\nStrong understanding of Software Development Life Cycle (SDLC), risk management, and change control processes.\nExperience with systems such as ERP, MES, PLM, QMS, LIMS, or other regulated applications is preferred.\nStrong analytical, troubleshooting, and problem-solving skills.\nThe experience we're looking to add to our team:\n3+ years of experience performing Computer System Validation (CSV).\nExperience validating software used in medical device environments.\nKnowledge of FDA, ISO 13485, and GAMP 5 requirements.\nExperience with process interfaces, system integrations, and data integrity controls.\nExperience creating and maintaining validation deliverables and compliance documentation.\nAdvanced English proficiency.\nWhat you'll receive for the great work you provide:\nCompetitive Salary.\nLife & Medical Insurance.\nChristmas Bonus.\nFood Coupons.\nSaving Fund.\nKM09\nJob Category\nITRequired Skills:\nOptional Skills:\nFlex 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  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. 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