Validation Engineer
Vasudev GurramUnited StatesSENIORPosted 2h ago
Installation Qualification (IQ)Operational Qualification (OQ)Performance Qualification (PQ)Process ValidationEquipment ValidationTest Method ValidationFDA regulationsGood Manufacturing Practices (GMP)Root Cause Analysis (RCA)CAPAChange ControlRisk AssessmentQuality Management Systems (QMS)Technical writingDocumentationAnalytical skillsProblem-solvingCommunicationCollaboration
About the Role
We are looking for an experienced Validation Engineer to join our team in Texas. This role requires extensive experience in validation engineering within medical device, pharmaceutical, or biotech industries.
Key Responsibilities
• Develop, execute, and document validation protocols and reports
• Conduct Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
• Perform Process Validation, Equipment Validation, and Test Method Validation
• Manage deviations, Root Cause Analysis (RCA), CAPA, and Change Control
• Implement Risk Assessment and Quality Management Systems (QMS)
• Provide validation verification, troubleshooting, and manufacturing support
Requirements
• Bachelor’s degree in Engineering, Life Sciences, Biotechnology, or a related field
• 8+ years of experience in Validation Engineering within Medical Device, Pharmaceutical, or Biotech industries
• Strong experience with FDA regulations, Good Manufacturing Practices (GMP), and relevant industry standards
• Excellent technical writing, documentation, analytical, and problem-solving skills
• Strong communication and collaboration abilities