CSV Engineer

CSV Engineer (Dublin)OverviewNeoDyne is a leading engineering company specialising in industrial automation, digital manufacturing, and electrical engineering solutions. With a strong presence across multiple sectors, including Life Sciences, Food & Beverage, and Energy, NeoDyne delivers leading-edge solutions that drive efficiency, safety, and performance for its customers worldwide. With a team of 220+ skilled engineers, our expertise spans the entire project lifecycle, from design and implementation to commissioning and operations. From our offices in Ireland, the UK, Romania, and the US, we operate on a global scale, combining technical expertise with local delivery. We support customers across Europe, North America, and Asia, delivering tailored engineering services that drive long-term success.Position SummaryNeoDyne is seeking an experienced CSV (Computer System Validation) Engineer to support one of our key client sites on a contract basis. The successful candidate will work closely with the NeoDyne team and play a critical role in delivering automation expertise across the Dublin based site.This role will provide validation support for the Emerson DeltaV Distributed Control System (DCS) at a biologics manufacturing site. The role involves ensuring compliance with GxP regulations, 21 CFR Part 11, and data integrity requirements while supporting validation lifecycle activities.Key ResponsibilitiesDevelop and execute Computer System Validation (CSV) documentation for the DeltaV DCS platform.Author and review Validation Plans, User Requirements Specifications (URS), Functional Design Specifications (FDS), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).Ensure compliance with GMP, GAMP 5, FDA 21 CFR Part 11, EU Annex 11, and Data Integrity guidelines.Conduct risk assessments and ensure adherence to change control procedures.Support Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), and commissioning activities from a validation perspective.Work closely with automation, IT, and quality teams to align validation activities with regulatory and business requirements.Troubleshoot CSV issues and support audit and inspection readiness efforts.Maintain and update validation documentation throughout the system lifecycle.Experience & SkillsRequired4+ years of experience in Computer System Validation (CSV) within the biopharmaceutical or life sciences industry.Strong knowledge of GxP, GAMP 5, FDA 21 CFR Part 11, and EU Annex 11 regulations.Hands-on experience in validating DeltaV DCS or similar automation systems.Proficiency in writing and executing URS, FDS, DQ, IQ, OQ, PQ, and test scripts.Experience with risk assessments, change management, and deviation handling.Strong understanding of data integrity principles and regulatory expectations.Excellent documentation, communication, and stakeholder management skills.DesiredExperience with Emerson DeltaV v13+ or higher.Knowledge of PLC, MES, and other automation systems in a GMP environment.Familiarity with audit preparation and regulatory inspection support.Understanding of IT infrastructure, cybersecurity, and network architecture for validated systems.Experience working in large-scale biologics or pharmaceutical facilities.CharacteristicsWe look for candidates whoWork well as part of a team.Have excellent problem solving and diagnostic skills.Can complete tasks independently, capable of self-learning.Can prioritise and coordinate work.Have excellent customer service, interpersonal, communication and organisational skills.Can multitask and work well under pressure.Are a strategic business thinker.What’s on OfferCompetitive hourly rate based on experiencePaid overtime available, depending on project demandsFlexible working hours may be accommodated in line with project requirementsOpportunity to work on a high-profile biopharma site with a collaborative, technically strong teamChance to be part of NeoDyne’s network of engineering professionals, contributing to impactful automation solutions in the life sciences sectorNeoDyne Ltd is an equal opportunity employer, and all applications will be treated in strictest confidence.