Senior Engineer Validation

Work Flexibility: Hybrid **What you will do:** * Support new product and process introductions in accordance with Product Development Process (PDP), Design Controls, and Quality System requirements. * Collaborate with R&D, Manufacturing Engineering, Quality, Regulatory, and Operations teams to industrialize and transfer new products into manufacturing. * Participate in manufacturing readiness activities including pilot builds, process characterization, verification, and production ramp up . Should have strong understanding of the difference between verification and validation. * Develop, execute, and maintain validation documentation including Validation Plans, Risk Assessments, Protocols, Traceability Matrices, and Final Reports. * Lead and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities for manufacturing equipment, processes, tooling, fixtures, and production systems. * Support Master Validation Planning and validation lifecycle management activities. * Ensure validation activities comply with GMP, FDA, ISO 13485, and internal quality requirements. **What you will need:** **Required Qualifications:** * Bachelor's degree in Mechanical Engineering, Electrical Engineering, Electronics Engineering, Industrial Engineering, Manufacturing Engineering, or a related technical discipline. * Minimum 6+ years of experience in Validation Engineering, Manufacturing Engineering, Quality Engineering, or a related discipline within medical devices, pharmaceuticals, biotechnology, or other regulated industries. * Hands-on experience executing IQ/OQ/PQ protocols for equipment, processes, tooling, fixtures, and manufacturing systems. * Experience with reviewing test requirements derived from product requirements Validation and End-of-Line (EOL) Tester qualification and validation. * Working knowledge of Computer System Validation (CSV) methodologies and regulatory expectations. * Strong understanding of GMP, FDA Quality System Regulation (21 CFR Part 820), ISO 13485, ISO 60601, and risk management principles. **Preferred Qualification:** ---------------------------- * Experience with PFMEA, Control Plans, PPAP, and process qualification methodologies. * Working knowledge of MSA, Gage R&R, process capability analysis, and statistical tools such as Minitab. * Experience supporting New Product Development (NPD), design transfer, and manufacturing scale-up activities. * Strong problem-solving, project management, and technical documentation skills. * Excellent communication skills and ability to collaborate effectively across multidisciplinary global teams.   Travel Percentage: 20%