Automation CSV Engineer
Posted 16 days 10 hours ago by Horizon Controls Group
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.
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.
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
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
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