Validation Engineer

HCLTech; Tijuana; Presencial; MXN 859.402 - 1.203.162; Jornada completa

Descripción de la vacante

HCLTech is looking for a Validation Engineer in Tijuana, Baja California. The role involves executing end-to-end validation and re-validation activities for processes, test methods, and measurement systems. The ideal candidate holds a Bachelor’s degree in a related engineering field and has 2–5 years of relevant experience in validation engineering. Knowledge of regulatory standards like ISO 13485 and hands-on experience with validation documentation is essential. Join HCLTech to contribute to industry-leading technology services.

Formación

• Bachelor’s degree in relevant engineering field.
• Strong understanding of validation principles including IQ/OQ/PQ.
• Knowledge of ISO 13485 and FDA regulations.

Responsabilidades

• Develop and execute validation plans and protocols.
• Perform process validation and test method validation.
• Update validation documents and maintain records in QMS.

Conocimientos

Validation principles (IQ/OQ/PQ)

Test Method Validation (TMV)

Measurement System Analysis (MSA)

Analytical skills

Statistical skills

Educación

Bachelor’s degree in mechanical, industrial, biomedical, or related engineering field

Herramientas

Minitab

JMP

Descripción del empleo

HCLTech is a global technology company, home to more than 223,000 people across 60 countries, delivering industry-leading capabilities centered around digital, engineering, cloud and AI, powered by a broad portfolio of technology services and products. We work with clients across all major verticals, providing industry solutions for Financial Services, Manufacturing, Life Sciences and Healthcare, High Tech, Semiconductor, Telecom and Media, Retail and CPG and Public Services. Consolidated revenues as of 12 months ending June 2025 totaled $14 billion. To learn how we can supercharge progress for you, visit hcltech.com.

Role Summary

The Validation Engineer is responsible for executing end‑to‑end validation and re‑validation activities for processes, test methods, equipment, tools, software, and measurement systems in compliance with quality and regulatory standards.

Key Responsibilities

• Develop and execute Validation Plans, Protocols (IQ/OQ/PQ), and Reports.
• Perform Process Validation, Test Method Validation (TMV), and periodic re-validation.
• Conduct Manufacturing Station Qualification and Tool Qualification.
• Perform Measurement System Analysis (MSA) including Gage R&R.
• Execute Non‑Product Software Validation (NPSV) as per software validation lifecycle.
• Update validation documents and maintain records within the Quality Management System (QMS).
• Collaborate with Manufacturing, Quality, and Engineering teams to support project needs.

Qualifications

• Bachelor’s degree in mechanical, Industrial, Biomedical, or related engineering field.
• Strong understanding of validation principles (IQ/OQ/PQ), TMV, MSA, and equipment qualification.
• Knowledge of ISO 13485, FDA 21 CFR Part 820, GAMP guidelines, or similar regulated-industry standards.
• Good analytical, documentation, and statistical skills.

Work Experience

• 2–5 years of experience in Validation Engineering or Quality/Manufacturing Engineering roles.
• Hands‑on experience performing process validation, test method validation, and equipment/tool qualification.
• Prior exposure to measurement system analysis and statistical tools (e.g., Minitab, JMP).
• Experience working in a regulated industry such as medical devices, automotive, pharma, or precision manufacturing.
• Experience generating or reviewing validation documentation—including plans, protocols, and reports.