Process Validation Engineer

• Develop, execute, and maintain process validation protocols and reports in accordance with established quality standards.
• Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for manufacturing equipment and processes.
• Support equipment qualification, process verification, and validation activities in medical device manufacturing.
• Prepare and maintain validation documentation, including protocols, test results, reports, and supporting records.
• Utilize PLM Agile to manage engineering documentation, change orders, and document revisions.
• Coordinate engineering change orders (ECOs), change management activities, and Design/Manufacturing Change Orders (DMCOs), as applicable.
• Ensure compliance with FDA regulations, ISO 13485 standards, and internal Quality Management System (QMS) procedures.
• Conduct risk assessments and Failure Mode and Effects Analysis (FMEA) to identify and mitigate manufacturing and process risks.
• Manage change control activities and assess the impact of process, equipment, material, and manufacturing changes on validated processes.
• Support CAPA investigations, deviation investigations, root cause analysis, and implementation of corrective and preventive actions.
• Develop and maintain validation plans, risk assessments, and other quality and engineering documentation.
• Support manufacturing transfer projects, including process transfer, validation planning, and production readiness activities.
• Collaborate with Quality Assurance, Manufacturing Engineering, Research and Development, and other cross-functional teams to resolve validation and manufacturing issues.
• Identify opportunities for continuous improvement in manufacturing processes, equipment performance, and validation systems.
• Ensure validation activities are completed on schedule and comply with applicable regulatory and company requirements.

Education & Experience :

• A master's degree in Engineering or a related field is preferred but not required.
• 3–5+ years of experience in process validation, equipment qualification, or manufacturing engineering, preferably in the medical device industry.
• Hands-on experience developing and executing IQ, OQ, and PQ protocols.
• Experience with PLM Agile, engineering change orders, and DMCO processes.
• Working knowledge of FDA regulations, ISO 13485, and Quality Management Systems.
• Experience with risk assessment methodologies, including FMEA.
• Experience in validation documentation, change control, CAPA, deviation investigations, and root cause analysis.
• Exposure to manufacturing transfer projects, process improvements, and production support activities.
• Strong technical writing, analytical, problem-solving, and cross-functional communication skills.