Process Validation Engineer

8 - 10 years

7.0 - 17.0 Lacs P.A.

Pune

Posted:2 months ago| Platform: Naukri logo

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Skills Required

MinitabShop FloorMedical DevicesOQGdpStatistical ToolsDocumentation SkillsDmrIQAnovaDoe

Work Mode

Work from Office

Job Type

Full Time

Job Description

Relevant 6-8 years having Electromechanical Background. Strong experience in creating and managing documentation, such as Good Documentation Practices (GDP), in regulated industries like medical devices, pharmaceuticals, and aerospace. Proficient in statistical tools such as Minitab, with experience in techniques like ANOVA, t-tests (1t, 2t), Gage R&R, DOE (Design of Experiments), Monte Carlo simulations, and understanding statistical concepts like resolution. Solid understanding of translating Design Master Records (DMR) into production processes, with knowledge of both R&D and manufacturing activities (similar to roles like an industrialization engineer at Philips). Proven ability to communicate clearly and collaborate with global stakeholders, and effectively manage multiple manufacturing activities across teams. Experience performing and guiding product validation tests (such as TMV, IQ, OQ, and PQ) directly on the shop floor. Ideally, a background in verification or validation within regulated industries.

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