Process Validation Engineer

Exp : Overall 3-4 years

Education : BE / B.Tech / ME / M.Tech

Work Location: Pune

Skill Requirement

• Good in documentation ( E.g. GDP , in earlier exp if person is author of doc and worked in regulated industries like Medical device , Pharma & Aero space etc)
• Experience with statistics
• Effective communication to have proper discussion (exp in handling manufacturing activities)
• Hands-on mentality to perform PV related activities (e.g TMV, IQ, OQ & PQ)
• Hands on shop floor is preferable
• Perform gap assessment and conduct remediation of documents with stakeholder inputs.
• Good understanding on the manufacturing specific QMS documents for Class-I, II and III medical devices.
• Supports the development and introduction of new products, processes, and technologies, with focus on quality systems
• Development, regulatory compliance, and process risk management including pFMEA.
• Creation/modification of process flows within the Manufacturing/Service Departments.
• Development and maintenance Manufacturing/Service Work Instructions and related documents.
• Creation/modification of fixtures, tooling, equipment, and systems to support operations.
• IQ, OQ, and PQ of fixtures, tooling, and equipment.
• Monitor and drive corrective action, CAPA and continuous improvement activities that directly impact performance measures by performing primary investigations, conducting data analysis, and implementing corrective actions.
• Support corrective and preventive actions in manufacturing using formal problem-solving tools and documentation.
• Medical Device Experience with knowledge of FDA 510 K, IS013485, ISO 14971 standards preferred