Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Automation/Computer System Validation Engineer

Responsibilities:

• Ensure the compliance and operational efficiency of our PCS through effective validation practices.

• Develop and execute comprehensive validation plans, protocols, and reports for PCS hardware, software, and applications, in accordance with regulatory requirements (e.g., FDA 21 CFR Part 11, GAMP 5) and industry best practices.

• Design and implement test automation scripts using scripting languages (e.g., Python, Visual Basic) and testing frameworks (e.g., Selenium, NUnit).

• Conduct risk assessments to identify potential areas of non-compliance and develop mitigation strategies.

• Perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for PCS new/expansion of existing Delta V system.

• Develop IQ, OQ and PQ protocols for hardware and software related to workstations, control network panels, I/O panels, control modules, etc.

• Review vendor documentation and specifications related to test automation tools.

• Investigate and troubleshoot issues related to automated tests.

Essential Skills/Experience:

• Bachelor’s Degree, preferably in Engineering.

• Expertise working knowledge of PLC systems, Process Control Systems (PCS) or distributed control systems (Delta V).

• Strong understanding of GAMP® 5 guidelines and other relevant regulatory requirements for automation validation.

• Experience with scripting languages and testing frameworks used in test automation.

• Advanced understanding of instrumentation and control loop programming.

• Advanced understanding of risk assessment and mitigation.

• Technical Writing skills and investigations processes.

• Project management knowledge.