Medical Device CSV Software Validation Engineer (FDA/ISO)

Flex; Aguascalientes; On-site; MXN 600,000 - 900,000; Full time

Benefits offered by this job

Competitive Salary

Life & Medical Insurance

Christmas Bonus

Food Coupons

Saving Fund

KM09

Job summary

Flex is seeking an IT Software Validation Engineer in Aguascalientes, Mexico, to validate software for regulated environments in medical device manufacturing. You will develop and execute CSV activities, create validation documentation, and ensure data integrity across systems.

You will collaborate with IT, Quality, Engineering, Manufacturing and Regulatory teams, support audits, and drive improvements in validation processes while maintaining compliance with applicable regulations.

Qualifications

• Bachelor's degree in Computer Science, IT or related discipline.
• Minimum 3 years in CSV/Software Validation within Medical Device/Life Sciences.
• Advanced English communication skills (written & verbal).
• Strong knowledge of FDA 21 CFR Part 11.
• Working knowledge of ISO 13485 and GAMP 5 methodologies.
• Experience validating software systems in regulated environments.
• Experience with SDLC, risk management and change control processes.
• Experience with ERP, MES, PLM, QMS, LIMS or similar systems.

Responsibilities

• Develops and executes CSV activities for software in medical device manufacturing and quality systems.
• Creates, reviews, and approves validation docs: URS, FS, IQ/OQ/PQ, risk assessments, and reports.
• Validates new software systems, upgrades and customized solutions in regulated environments.
• Ensures compliance with FDA regulations including 21 CFR Part 11.
• Applies GAMP 5 principles and risk-based validation throughout lifecycle.
• Evaluates interfaces, data integrations and customizations for data integrity.
• Collaborates with IT, Quality, Engineering, Manufacturing and Regulatory teams.
• Supports audits and regulatory inspections with validation evidence.
• Participates in change management and assesses validation impact of modifications.
• Ensures ongoing compliance via periodic reviews and revalidation.
• Identifies opportunities for continuous improvement in validation processes.

Skills

Advanced English

Analytical thinking

Regulatory compliance

Education

Bachelor's degree in Computer Science or related field

Tools

ERP

MES

PLM

QMS

LIMS

Job description

Flex is seeking an IT Software Validation Engineer in Aguascalientes, Mexico, to validate software for regulated environments in medical device manufacturing. You will develop and execute CSV activities, create validation documentation, and ensure data integrity across systems.

You will collaborate with IT, Quality, Engineering, Manufacturing and Regulatory teams, support audits, and drive improvements in validation processes while maintaining compliance with applicable regulations.