Automation CSV Engineer - GMP Validation & DCS/SCADA

Horizon Controls Group; Dublin; On-site; EUR 90,000 - 120,000; Full time

Job summary

Horizon Controls Group in Ireland seeks an experienced Automation CSV Engineer to validate and maintain automated control systems in a GMP environment. You will collaborate with automation engineers, quality, IT, and manufacturing to deliver inspection-ready systems.

The role leads CSV activities, develops validation docs (URS, FRS, IQ, OQ, PQ), ensures compliance with 21 CFR Part 11 / EU Annex 11, and supports audits, change control, and lifecycle documentation.

Qualifications

• Proven experience as a CSV Engineer within pharmaceutical or life sciences manufacturing.
• Strong understanding of automation systems validation.
• Hands-on experience with validation of DCS / PLC / SCADA systems.
• In-depth knowledge of GMP, GAMP 5, and data integrity principles.
• Experience working with 21 CFR Part 11 / EU Annex 11 requirements.
• Excellent documentation and reporting skills.
• Strong stakeholder engagement and communication abilities.

Responsibilities

• Lead and support CSV activities for automation and control systems.
• Develop, review, and execute validation documentation including URS, FRS, HDS, SDS, RA, IQ, OQ, PQ.
• Ensure compliance with GAMP 5, GMP, and 21 CFR Part 11 / Annex 11.
• Support validation of DeltaV DCS, PLC, SCADA, and associated systems.
• Participate in FAT and SAT activities from a CSV perspective.
• Perform risk assessments and define validation strategies for new and existing systems.
• Support audits and regulatory inspections (HPRA, FDA, EMA).
• Manage change control, periodic reviews, and system lifecycle documentation.
• Collaborate with automation, quality, IT, and vendor teams.

Skills

CSV Engineer

Automation validation

GMP knowledge

Regulatory compliance

Documentation skills

Tools

Emerson DeltaV

Job description

Horizon Controls Group in Ireland seeks an experienced Automation CSV Engineer to validate and maintain automated control systems in a GMP environment. You will collaborate with automation engineers, quality, IT, and manufacturing to deliver inspection-ready systems.

The role leads CSV activities, develops validation docs (URS, FRS, IQ, OQ, PQ), ensures compliance with 21 CFR Part 11 / EU Annex 11, and supports audits, change control, and lifecycle documentation.