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Process Validation Engineer

Process Validation Engineer

GLOINNT

3 - 7 years

0 Lacs

pune maharashtra

Posted:19 hours ago| Platform: Shine logo

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Skills Required

effective communication regulatory compliance equipment iq oq good in documentation experience with statistics handson mentality perform pv related activities perform gap assessment good understanding on qms documents supports development of new products process risk management creationmodification of process flows development maintenance of work instructions creationmodification of fixtures tooling systems pq of fixtures tooling equipment monitor drive corrective action support corrective preventive actions medical device experience

Work Mode

On-site

Job Type

Full Time

Job Description

Role Overview: You will be responsible for supporting the development and introduction of new products, processes, and technologies with a focus on quality systems. Your role will involve creating/modifying process flows, work instructions, and related documents within the Manufacturing/Service Departments. Additionally, you will be involved in the creation/modification of fixtures, tooling, equipment, and systems to support operations. You will also be required to perform IQ, OQ, and PQ of fixtures, tooling, and equipment. Key Responsibilities: - Good understanding of documentation practices, especially in regulated industries like Medical device, Pharma & Aerospace - Experience with statistics and effective communication skills for proper discussions, particularly in handling manufacturing activities - Hands-on mentality to perform PV related activities such as TMV, IQ, OQ & PQ - Preferably have hands-on experience on the shop floor - Conduct gap assessments and facilitate the remediation of documents with stakeholder inputs - Familiarity with manufacturing-specific QMS documents for Class-I, II, and III medical devices - Development, regulatory compliance, and process risk management including pFMEA - Monitor and drive corrective action, CAPA, and continuous improvement activities by conducting primary investigations, 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, ISO 13485, ISO 14971 standards preferred Qualifications Required: - Bachelor's or Master's degree in BE/B.Tech/ME/M.Tech - Minimum of 3-4 years of experience in a similar role - Strong expertise in documentation, statistics, and effective communication - Hands-on experience in manufacturing activities and PV related activities - Knowledge of FDA 510 K, ISO 13485, and ISO 14971 standards would be advantageous,

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GLOINNT

Technology / Data Analytics

San Francisco

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Process Validation Engineer