Validation Support Engineer - cGxPServe : Job Details

Validation Support Engineer

cGxPServe

Job Location : Boston,MA, USA

Posted on : 2025-07-18T01:33:26Z

Job Description :

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  • We are seeking an experienced Validation Support Engineer to lead validation activities for Beckhoff Twin CAT PLC-controlled systems in a 24/7 GMP-regulated manufacturing environment.
  • The role focuses on ensuring compliance with FDA regulations (21 CFR Part 11, 210, 211, 820), GAMP5 methodologies, and internal quality standards.
Job Description
  • We are seeking an experienced Validation Support Engineer to lead validation activities for Beckhoff Twin CAT PLC-controlled systems in a 24/7 GMP-regulated manufacturing environment.
  • The role focuses on ensuring compliance with FDA regulations (21 CFR Part 11, 210, 211, 820), GAMP5 methodologies, and internal quality standards.
Responsibilities:
  • Develop/update Validation Plans (VP) and Master Validation Plans (MVP).
  • Lead GxP risk assessments for system changes.
  • Author and execute IQ/OQ/PQ protocols.
  • Maintain Requirements Traceability Matrices (RTM).
  • Investigate and manage deviations; support RCA and CAPA processes.
  • Create Validation Summary Reports (VSR).
  • Ensure full compliance with regulatory and quality standards.
Requirements:
  • 5 8 years of experience in Computer System Validation (CSV).
  • Strong knowledge of FDA regulations and GAMP5.
  • Hands-on experience validating PLC-controlled systems.
  • Beckhoff Twin CAT PLC and Ether CAT hardware experience is a strong plus.
Seniority level
  • Seniority levelMid-Senior level
Employment type
  • Employment typeFull-time
Job function
  • Job functionInformation Technology
  • IndustriesResearch Services

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