Principal Validation Engineer

Job description

Key Skills: Validation, Process Validation, System Validation, Equipment Qualification, cGMP, GxP, SOPs, CAPA, Risk Assessment, DOE, SPC, Cp/Cpk, Process Optimization, Quality Compliance Roles & Responsibilities: • Lead validation projects and develop validation strategies for process, system, and equipment qualification activities. • Prepare, review, and maintain validation protocols, reports, and technical documentation in line with regulatory and quality requirements. • Conduct risk assessments, investigate technical issues, and support CAPA actions using structured problem-solving methods. • Apply statistical tools such as DOE, SPC, and Cp/Cpk to support process monitoring and improvement initiatives. • Support compliance with cGMP, SOPs, and GxP requirements while driving continuous improvement in quality and efficiency. Experience: • 7 to 12 years of relevant validation experience in a regulated manufacturing environment. • Hands-on validation experience across process, system, and equipment environments. • Strong protocol and documentation capability for regulated manufacturing operations. • Risk assessment and process optimization experience in a quality-driven setting. • Ability to support compliance, technical problem solving, and data-based decision making. Good to Have: • Medical device or pharmaceutical manufacturing background. • Experience with GxP validation practices and GxP compliance. • Project management exposure in validation or quality programs. • Experience preparing reports for regulated environments. Education: • Bachelor's degree in Engineering, Life Sciences, Pharmacy, or related discipline.