Automation CSV Engineer

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 are looking to hire an experienced Automation Computer System Validation (CSV) Engineer to support pharmaceutical manufacturing systems within a regulated GMP environment. This role is ideal for a validation professional with strong automation exposure who enjoys working at the intersection of compliance, technology, and operations.

About the Role

The Automation CSV Engineer will be responsible for ensuring that automated control systems are validated and maintained in compliance with regulatory requirements and industry best practices. You will work closely with automation engineers, quality, IT, and manufacturing teams to deliver compliant and inspection-ready systems.

Key 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

Required Experience & Skills

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

Desirable (Nice to Have)

Experience validating Emerson DeltaV systems

Exposure to MES, Historian, or laboratory systems

Experience supporting site expansions, system upgrades, or remediation projects

Familiarity with data integrity assessments and cybersecurity considerations