Computer System Validation Engineer

3 weeks ago


United Kingdom PQE Group Full time

Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries ? Develop and execute validation protocols for computer software systems used in automated process manufacturing equipment, with a specific focus on DeltaV-controlled systems.
Collaborate with engineering, operations, and quality assurance teams to define validation requirements, ensuring alignment with regulatory standards (e.g., Perform risk assessments and gap analyses to identify potential areas of concern in the validation process, proposing and implementing mitigation strategies as needed.
Conduct testing and verification activities, including software installation qualification (SIQ), operational qualification (OQ), and performance qualification (PQ), in accordance with approved protocols.
Troubleshoot and resolve validation issues, working closely with technical teams to address any discrepancies or deviations encountered during testing.
Maintain validation documentation in a compliant and organized manner, ensuring traceability and accessibility for audits and regulatory inspections.
Stay informed about industry trends, regulatory updates, and advancements in validation methodologies, incorporating best practices into our validation processes.
Provide technical guidance and mentorship to junior validation engineers, fostering a culture of excellence and continuous improvement within the validation team.


Bachelor's degree in Engineering, Computer Science, or related field. 8-10 years of experience in computer software validation, with a focus on automated process manufacturing equipment, particularly DeltaV-controlled systems .
~ Familiarity with regulatory requirements and standards governing automated process manufacturing, such as 21 CFR Part 11, GAMP 5, and IEC 62304.
~ Proven track record of successfully leading validation projects and delivering results on schedule and within budget.


PQE Group gives you the opportunity to work on international projects , improve your skills and interact with colleagues from all corners of the world.



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