Automation CSV Engineer

Horizon Controls Group; Tipperary; On-site; EUR 65,000 - 90,000; Full time

Job summary

Horizon Controls Group is seeking a CSV Engineer to join the DDQ team on a site restructuring project for a major pharma client. You will provide independent compliance oversight for CSV, SDLC, CyberSecurity and Data Integrity across DeltaV DCS and PLC/SCADA and other manufacturing systems.

You will review lifecycle docs, change controls, investigations and deviations, ensuring a consistent qualification strategy and timely DDQ support to keep project timelines on track.

Qualifications

• Min. 5 years of experience in QA IT/CSV in the pharmaceutical industry.
• Working knowledge of relevant regulations and industry standards.
• Proven ability to meet timelines and engage with stakeholders.

Responsibilities

• Providing independent quality review and approval of system lifecycle documentation for new and modified systems.
• Providing independent quality review and approval of system changes.
• Supporting and approving computerised systems investigations and test deviations.
• Ensuring consistent approach to qualification, change and deviation management across systems on the project.
• Providing timely and pro-active DDQ support and guidance to facilitate project timelines.

Skills

CSV/QA knowledge

Regulatory knowledge

Stakeholder engagement

Project management (advantage)

Tools

DeltaV DCS

PLC/SCADA

Job description

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.