Atl01-022125 Automation/Computer Systems Validation Engineer_Sc

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.

We are seeking a highly skilled and dedicated professional with strong expertise in Computer Systems Validation (CSV) for Programmable Logic Controllers (PLCs) and Process Control Systems (PCS). The ideal candidate will ensure compliance, reliability, and operational efficiency of automated systems within a regulated environment.

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:

• Bachelors 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.