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Automation csv engineer

Dundalk
Horizon Controls Group
Engineer
Posted: 26 February
Offer description

Automation CSV Engineer (Pharmaceutical)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 RoleThe 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 ResponsibilitiesLead and support CSV activities for automation and control systemsDevelop, review, and execute validation documentation including URS, FRS, HDS, SDS, RA, IQ, OQ, PQEnsure compliance with GAMP 5, GMP, and 21 CFR Part 11 / Annex 11Support validation of DeltaV DCS, PLC, SCADA, and associated systemsParticipate in FAT and SAT activities from a CSV perspectivePerform risk assessments and define validation strategies for new and existing systemsSupport audits and regulatory inspections (HPRA, FDA, EMA)Manage change control, periodic reviews, and system lifecycle documentationCollaborate with automation, quality, IT, and vendor teamsRequired Experience & SkillsProven experience as a CSV Engineer within pharmaceutical or life sciences manufacturingStrong understanding of automation systems validationHands-on experience with validation of DCS / PLC / SCADA systemsIn-depth knowledge of GMP, GAMP 5, and data integrity principlesExperience working with 21 CFR Part 11 / EU Annex 11 requirementsExcellent documentation and reporting skillsStrong stakeholder engagement and communication abilitiesDesirable (Nice to Have)Experience validating Emerson DeltaV systemsExposure to MES, Historian, or laboratory systemsExperience supporting site expansions, system upgrades, or remediation projectsFamiliarity with data integrity assessments and cybersecurity considerations

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