Validation Engineer

Key Responsibilities:Develop, write, and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.Perform validation of manufacturing equipment, utilities, cleaning processes, computer systems, and laboratory instruments.Ensure compliance with GMP, FDA, ISO, and other regulatory guidelines.Review and analyze validation test data, prepare summary reports, and maintain accurate documentation.Collaborate with cross-functional teams (Engineering, QA, Manufacturing, R&D) to support validation and qualification activities.Participate in risk assessments, deviation investigations, and CAPA implementation.Ensure all validation activities align with Quality Management System (QMS) requirements.Support audits and inspections by regulatory authorities and customers.Maintain up-to-date knowledge of industry standards, validation best practices, and regulatory expectations.Qualifications & Skills:Bachelor’s degree in Engineering, Life Sciences, or a related field.Proven experience in validation engineering within Pharmaceutical, Biotechnology, Medical Devices, or Manufacturing industries.Strong knowledge of cGMP, GLP, and regulatory compliance standards (FDA, EMA, ISO, ICH, GAMP 5).Hands-on experience with equipment qualification, process validation, cleaning validation, or computer system validation (CSV).Strong technical writing, documentation, and communication skills.Ability to manage multiple validation projects simultaneously.Preferred Skills (Nice to Have):Experience with automation systems, ERP, or laboratory information systems (LIMS/ELN).Familiarity with statistical tools and risk management approaches.Six Sigma or Lean Manufacturing knowledge.Prior involvement in FDA or ISO audits.👉 Do you want me to prepare this JD specifically for Medical Devices / Pharma validation engineer, or keep it as a general validation engineer JD for all industries?