Validation Engineer

Overview

The Validation Engineer is responsible for planning, coordinating, and executing validation activities to ensure that manufacturing processes consistently produce products that meet predefined quality standards. This role includes developing validation protocols, analyzing data, and preparing comprehensive reports in compliance with regulatory and quality requirements (e.g., FDA, ISO 13485).

Responsibilities

• Develop and execute validation protocols (IQ, OQ, PQ) in accordance with regulatory guidelines.
• Conduct risk assessments and define validation strategy for new and existing manufacturing processes.
• Analyze process performance data and identify opportunities for improvement and optimization.
• Prepare and maintain validation documentation, including protocols, reports, deviations, and change controls.
• Collaborate with cross-functional teams including Quality, and Manufacturing.
• Support audits and inspections by regulatory bodies and customers.
• Ensure compliance with industry regulations (e.g., FDA, GMP, ISO) and company standards.
• Train and support production teams on processes and equipment.
  
  

• B.Sc in engineering (Mechanical, Biomedical, Chemical, or related field ). M.Sc is an advantage..
• 2–5 years of experience in NPI and validation within a medical device or pharmaceuticals industry.
• Strong knowledge of validation principles and regulatory standards (21 CFR Part 820, ISO 13485, etc.).
• Experience with statistical tools and software (e.g., Minitab) is an advantage.
• Excellent documentation and communication skills in English.
• Detail-oriented with strong analytical and problem-solving abilities.