Validation Support Engineer

Overview

On Site
Full Time

Skills

GMP
Manufacturing
MVP
GxP
Risk Assessment
IQ
OQ
PQ
Requirements Traceability
RTM
Management
Root Cause Analysis
Corrective And Preventive Action
Regulatory Compliance
Computerized System Validation
GAMP
Programmable Logic Controller
Computer Hardware

Job Details

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.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.