Process Validation - Medical devices

4 - 8 years

8 - 13 Lacs

Posted:3 hours ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

Role & responsibilities

Job Title Manufacturing Engineer/Process Validation Engineer

Location – Chennai

Delivery looking immediate joiner only

  • Conduct detailed gap assessments of current manufacturing practices against applicable medical regulatory standards (e.g., FDA, ISO 13485, EU MDR, GMP).
  • Review process controls, equipment validation, and quality systems documentation to identify non-compliances and areas for improvement.
  • Identify systemic issues and risk areas related to manufacturing quality, process robustness, and compliance.
  • Support remediation activities including process updates, validation efforts, documentation revisions, and training plans.
  • Strong understanding of regulatory standards including

    FDA 21 CFR Part 820

    ,

    ISO 13485

    ,

    GMP

    , and

    EU MDR

    .
  • Familiarity with process validation (IQ/OQ/PQ), and quality management systems.

interested candidates, share your resume to venkateshp@hcltech.com

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HCLTech

Information Technology Services

New Delhi

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