Computer Systems Validation (CSV) Engineer NEW

Computer Systems Validation (CSV) Engineer | West of Ireland (Hybrid)

· Leading Pharma Company in the West of Ireland

· Excellent career progression opportunities along with a generous package

Oradeo Recruitment is presently seeking interest for an experienced Computer Systems Validation Engineer to join their European Team for our clients located in Mayo. Reporting to the Associate Director, Instrumentation Optimization this role will be responsible for building and maintaining the project management framework for  validation projects

Main Duties & Responsibilities:

  • Prepare validation deliverables for computerized systems, including Validation Plans, Requirements Specification, Configuration Specifications, Risk Assessments, Test Scripts, Traceability Matrices, and Validation Summary Reports.
  • Coordinate and schedule system vendors with respect to the execution of Installation, Operation, and Performance Qualification (IQ/OQ/PQ) protocols, and subsequent Re-Qualification (RQ) protocols if applicable for new and in-use equipment to ensure compliance with site procedures, Master Validation Plan (MVP), and regulatory requirements.
  • Assist system SMEs in the preparation of test scripts comprising formal testing of functional, system and regulatory requirements in conjunction with computerized system validation. Oversee test script execution.
  • Work with Operations and Quality to assess risk and impact with respect to proposed changes within the facilities and validated processes. Participate in meetings associated with the scheduling of these activities to ensure minimal impact to existing operations.
  • Provide ongoing Qualification/Validation and other appropriate System Lifecycle training/education of staff.
  • Provide ongoing support for Data Integrity projects to identify and ensure the safeguarding of data in compliance with site procedures, regulatory requirements, and corporate policies.
  • Organize an efficient method to ensure all requirements of assigned validation deliverables are completed and that validation efforts are executed in a timely manner.
  • Participate in the development of corrective actions as needed for deficiencies that may be uncovered/observed during validation efforts in regards to equipment, processes, test methods, facilities, computer software/systems, SOPs, and other related issues in order to assure compliance with applicable regulatory requirements/guidelines, procedures and policies.
  • Participate in the development of CAPA’s and assess the effectiveness of the corrective action. Schedule validation project team meetings to assure project milestone schedules are maintained and deliverables satisfy requirements.
  •  Assist as needed during client and regulatory audits and help to resolve or mitigate audit findings related to system qualification/validation

The following are minimum requirements related to the CSV Engineer position:

  • BSc/MSc. in a relevant discipline.
  • 3+ years’ experience in validation & project management. Experience is preferable within the Pharmaceutical/Medical Device/CRO Industry but is not essential.
  • Project Management certification preferable.
  • Ability to manage multiple projects
  • Ability to problem solve and work on own initiative.
  • Proven communication and organizational skills required.

For more information about this position or other opportunities, contact Tara Ryan at Oradeo Recruitment confidentially on +353 1 687 7188 or apply in confidence.

About Oradeo – Oradeo Recruitment are specialists in the life sciences, pharmaceutical, construction & engineering sector. We are a leading service provider in Ireland, UK and Europe for professional recruitment services and the provision of managed labour in Construction & Civil Engineering, Data centres, Mechanical & Electrical, Life Sciences and Renewable Energies sectors.

Job Overview

  • Reference: 1781_TRC
  • Date Posted:
  • Location: Mayo
  • Job Title: Computer Systems Validation (CSV) Engineer
  • Salary: Negotiable
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