Position : 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