Validation Engineer

We are seeking a proactive Validation Engineer with 1–3 years of experience in a regulated manufacturing environment such as medical devices, pharmaceuticals, or biotechnology. This on -site role focuses on process validation activities to ensure compliance with FDA, ISO, cGMP, and internal quality standards while supporting continuous improvement and operational excellence.

• Develop, write, review, and execute process validation and process verification protocols and reports
  
• Conduct risk assessments and support validation strategies for new and existing manufacturing processes
  
• Analyze and interpret validation data to ensure compliance with regulatory and internal quality requirements
  
• Collaborate with Manufacturing, Quality, and Design Transfer teams to resolve validation issues and implement corrective actions
  
• Support process optimization and continuous improvement initiatives to improve quality and efficiency
  
• Ensure compliance with FDA, ISO, cGMP, and internal regulatory standards
  
• Maintain validation documentation, traceability records, and audit -ready files
  
• Provide training and guidance on validation processes, procedures, and compliance requirements
  

• Bachelor’s degree in Engineering, Life Sciences, or related field
  
• 1–3 years of experience in validation within a regulated manufacturing environment
  
• Knowledge of process validation principles, verification techniques, and industry standards
  
• Familiarity with FDA regulations, ISO standards, and cGMP requirements
  
• Strong technical writing, analytical, and problem -solving skills
  
• Excellent communication and cross -functional collaboration abilities
  

• Medical device, biotech, or pharmaceutical industry experience
  
• Experience supporting audits, CAPA activities, and process improvement initiatives
  
• Familiarity with risk assessments and validation documentation practices
  

Process Validation | Process Verification | FDA Compliance | cGMP | ISO Standards | Validation Protocols | Risk Assessments | CAPA | Technical Writing | Root Cause Analysis | Quality Systems | Continuous Improvement | Manufacturing Validation | Regulatory Compliance