Validation Engineer

Role: Validation Specialist overseeing qualification and validation activities in a cGMP pharmaceutical manufacturing environment. Primary objectives include ensuring manufacturing processes, utilities, and cleaning procedures remain validated and compliant with regulatory and industry standards. Responsibilities involve designing, scheduling, and executing validation experiments, preparing validation documentation (Master Plans, protocols, reports), and representing validation on cross-functional teams interacting with Manufacturing, MS&T, QC, R&D, and Regulatory agencies. The role demands risk-based validation strategy development, troubleshooting validation issues, supporting deviations and CAPAs, and facilitating compliance during inspections. It also includes identifying validation gaps, contributing to validation concept updates, and driving continuous process improvement. Requirements: Degree in Engineering, Physical, or Biological Science preferred; 3+ years in pharmaceutical quality or operations within a cGMP setting. Experience with US and international validation regulations, utilities, facilities, and equipment qualification is preferred. Competencies include strong communication, decision-making, problem-solving, and results orientation. High-Value: cGMP validation, pharmaceutical manufacturing, utilities, cleaning validation, regulatory compliance, risk assessments, process validation, cross-functional collaboration, inspection readiness. WorkSetup: Not specified.