Tipperary, Ireland | Posted on 07/09/2025Horizon Controls Group is hiring a CSV Engineer to assist at a client site.Responsibilities include:Reporting to the Project Manager and CSV Lead, focusing on Computer System Validation.Developing key quality documents such as Quality Assurance Plans (QAPs), Requirements Traceability Matrices, and summary reports, ensuring compliance with MSD and regulatory standards.Collaborating with teams responsible for Automation and IT scope, as well as vendors and partners involved in system delivery.Reviewing vendor compliance with quality standards.Representing the CSV function in Automation, IT, and other project meetings.Acting as the CSV SME and providing standardized CSV approaches across projects.Developing and maintaining Qualification and Test Plans aligned with project strategies.Creating templates for SDLC deliverables, including Requirements Specification, Traceability Matrix, Functional and Design Specifications, and Test Scripts.Ensuring deliverables meet standards in collaboration with Digital Data and Quality functions.Approving SDLC deliverables and overseeing FAT activities.Guiding digital team members and supporting project schedules and document tracking.Working with suppliers to ensure compliance and participating in project meetings.Communicating project validation requirements with stakeholders.Qualifications and Skills:Fluent in English, written and verbal.Minimum 4 years’ experience in a similar role within the life sciences or pharmaceutical manufacturing.Expertise in GAMP5.Experience with Emerson DeltaV systems.Knowledge of DCS, Siemens PLC/SCADA, OSISoft PI, and Werum Pax-X is advantageous.Proficient in Microsoft Office tools: Excel, SharePoint, Word, PowerPoint.Strong communication and interpersonal skills.Relevant degree in Computer Science, Engineering, or equivalent.Experience with paperless validation systems like Kneat is a plus.This is a site-based role, with occasional meetings at vendor or other sites required.
#J-18808-Ljbffr