Automation CSV Engineer

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