Pharma CSV Compliance Engineer – Validation & SDLC

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

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.