HCLTech is a global technology company, home to more than 223,000 people in 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, Technology and Services, Telecom and Media, Retail and CPG, and Public Services. Consolidated revenues as of 12 months ending September 2024 totaled $13.7 billion. 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. 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. --- 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). --- We offer: Direct and indefinite hiring, 100% payroll schema, all law benefits Benefits above law (Major and minor medical insurance, Life Insurance, saving funds, grocery coupons, 30 days Christmas bonus, 12 days vacations, dental and optical plan) "For more information on how we process your personal data, please refer to the HCLTech Candidate Data Privacy Notice | HCLTech
Job Title
Validation Engineer