Tipperary, Ireland | Posted on 07/09/2025
Horizon 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.
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