Validation Support Engineer
Validation Support Engineer
Posted on :
04-06-2025
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1 Vacancy
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Job Description
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) GAMP5 methodologies and internal quality standards.
- 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.
- 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.
Employment Type
Full Time
Key Skills
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