OVERVIEW

NeoDyne is a leading Irish and UK Industrial Automation and Electrical Engineering company. Our B2B customer base extends to over 300 companies with turnover predominantly from large multinationals in pharma, high-end food and beverage manufacturing and energy sectors. The company is 25 years old and employs over 200 talented automation, electrical and IT engineers across offices in Dublin, Cork, Galway, Waterford, and Chesterfield, UK.
NeoDyne 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 site.
We are seeking an experienced Computer System Validation (CSV) Engineer to 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.

EXPERIENCE & SKILLS

Required
4+ 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.
Desired
Experience 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.

Develop 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.