Automation CSV Engineer

Tipperary, Ireland Posted on 11/26/2024

Horizon Controls Group have anexciting opening for a CSV Engineer with one of our major clients in the pharmaindustry.

The successful candidate willjoin the DDQ team on a site re-structuring project to provide independentcompliance oversight and support for the implementation of new shopfloorautomation systems and modifications to existing site systems. The DDQspecialist will ensure compliance with regulatory expectations and companyComputer Systems Validation (CSV), System Development Lifecycle (SDLC), CyberSecurity and Data Integrity requirements. The DDQ specialist will support anumber of shopfloor system, including, DeltaV DCS systems, PLC/SCADA systemsand other manufacturing systems.

Responsibilities

• Providing independent qualityreview and approval of system lifecycle documentation, such as plans,requirements, risk assessments, protocols and reports for new and modifiedsystems.
• Providing independent qualityreview and approval of system changes.
• Supporting and approvingcomputerised systems investigations and test deviations.
• Ensuring consistent approach toqualification, change and deviation management across systems being implementedon the project.
• Providing timely and pro-activeDDQ support and guidance to facilitate project timelines, including closecollaboration with the technical and business units.
• Where required, engaging withDDQ teams from other sites and capital projects to standardise and alignapproach to computerised systems compliance.

Experience

• Min. 5 years of experience inQA IT/CSV, CSV and/or a similar role in the pharmaceutical industry.
• Working knowledge of relevantregulations and industry standards.
• Proven ability to meettimelines, prioritise tasks and engage with stakeholders.
• Project management experiencewill be an advantage.