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ATL01-022125 Automation/Computer Systems Validation Engineer_SC
ATL01-022125 Automation/Computer Systems Validation Engineer_SCValidation & Engineering Group, Inc. • Greenville, SC, US
No longer accepting applications
ATL01-022125 Automation / Computer Systems Validation Engineer_SC

ATL01-022125 Automation / Computer Systems Validation Engineer_SC

Validation & Engineering Group, Inc. • Greenville, SC, US
10 days ago
Job type
  • Full-time
Job description

Overview

Validation & Engineering Group, Inc. (V&EG) is a leading service provider specializing in Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries. Our expertise covers Laboratory Compliance, CSV, Engineering, Project Management, Validation, and other technical services.

Responsibilities

  • Develop and execute validation plans, protocols (IQ, OQ, PQ), and reports for PLC-based automation and process control systems in accordance with FDA 21 CFR Part 11, GAMP 5, and industry best practices.
  • Conduct risk assessments to identify potential areas of non-compliance and develop mitigation strategies.
  • Ensure compliance of PCS hardware, software, and applications through effective validation practices.
  • Review and assess vendor documentation for automated control systems and test automation tools.
  • Troubleshoot and resolve issues related to automated control systems validation.
  • Design and implement test automation scripts for production and packaging equipment in regulated environment.
  • Develop IQ, OQ and PQ protocols for hardware and software related to production and packaging equipment of ophthalmic products.

Essential Qualifications & Skills

  • Bachelor's degree in Engineering or a related field.
  • Extensive knowledge of PLC systems and automation validation.
  • Strong understanding of GAMP 5 guidelines and other relevant regulatory requirements.
  • Experience with instrumentation and control loop commissioning & qualification (C&Q).
  • Expertise in risk assessment and mitigation strategies for automated systems.
  • Strong technical writing skills for validation documentation, reports, and investigations.
  • Project management skills with the ability to manage multiple validation tasks effectively.

    • Seniority level

  • Mid-Senior level

    • Employment type

  • Full-time

    • Job function

  • Strategy / Planning and Information Technology

    • Location : Greenville, SC

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