Job Description

Job Description:

  • The Manufacturing Validation Engineer will support medical device manufacturing operations by planning, executing, and documenting process, equipment, and measurement system validations.

  • This role ensures compliance with ISO 13485, GMP, and 21 CFR Part 820 requirements while partnering with cross-functional teams to qualify equipment, improve processes, and maintain a validated state.

  • The engineer will be responsible for creating validation protocols (IQ/OQ/PQ), performing statistical analysis, supporting calibration/metrology activities, and resolving validation-related quality issues.


Roles & Responsibilities:


  • Perform process validation planning, execution, and reporting according to regulatory and internal requirements.

  • Create and maintain validation documentation, including IQ, OQ, and PQ protocol...

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