CSV Specialist

22 hours ago

Nenagh, County Tipperary, Ireland beBeeValidation Full time €75,000 - €95,000
Computer System Validation Expert

This role involves assisting at a client site in Computer System Validation.

The successful candidate will have strong communication and interpersonal skills, as well as the ability to work effectively with cross-functional teams.

Responsibilities:
  • 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 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
Required Skills and Qualifications:
  • 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
Benefits:

This is a site-based role, with occasional meetings at vendor or other sites required.

This position offers a great opportunity to work with experienced professionals and contribute to the development of high-quality computer systems.