Computer Systems Validation (CSV) Specialist

Posted 8 March by ARJO

Position: CSV Specialist
Houghton Regis
Salary: £45000 - £55000


Arjo is a successful medical device manufacturer and distributor addressing Patient and Post-Acute Care (PPAC) needs in several countries. We have invested significantly in Computerized Quality Systems and we are recruiting for a Computer Systems Validation Specialist who will be a key player in this IT-CSV and QSR-CSV set up, interfacing with a wide variety of key stakeholders inside and outside the organization.

In this position you will ensure a global framework for Computerized Systems Validation (CSV) of IT systems handling quality data (GxP data) in compliance with regulatory requirements for medical devices, electronic records and electronic signatures.

This is a real opportunity for an individual looking for a varied role where you have the possibility to contribute to developing the quality and regulatory compliant organization.


  • Coordinate across IT function to validate systems as per CSV framework
  • Create and maintain CSV Procedures and Quality Policies and Guidelines
  • Create and Review Computer System Validation Documents and SDLC Documentation
  • Contribute to Change Control Process, Impact Analysis and Risk Assessments
  • Address and follow-up on deviations occurred during execution of qualification/validation activities
  • Conduct Periodic Reviews
  • Ensure Systems are maintained in a validated state via change control
  • Train Stakeholders in Computer Systems Validation Framework including preparation of training material
  • Train Stakeholders in Software Development Life Cycle including preparation of training material
  • Perform internal audits of CSV packages.
  • Participate in internal and external Q&E MS audits and external vendor audits.
  • Follow-up activities related to CSV resulting from (internal and external) audits, quality system initiatives (FIR, CAPA, QIP), MAP, etc.


  • Bachelor’s Degree in Computer Science or IT Engineering or equivalent
  • Past experience creating and reviewing documentation for Quality Systems or appropriate qualification in Business Systems Analysis preferred
  • Possess an understanding of Computerized System Validation and Software Development Life Cycle
  • Experience in developing and working with Quality IT systems and CAPA Systems.
  • Experience with project management and stakeholder management
  • Experience in delivering training
  • Knowledge of applicable regulations and standards, e.g. ISO 9001, ISO 13485, FDAs QSR and Part 11 and Part 820 or willingness to develop knowledge
  • Sound Knowledge of GAMP’s: (Global Information Systems, IT Infrastructure Control and Compliance, A Risk-Based Approach to Compliant Electronic Records and Signatures, Validation of Laboratory Computerized Systems, Testing of GXP Systems).
  • Knowledge of SW development and testing processes.
  • Experience in using Microsoft Word, Excel, PowerPoint, Visio and SharePoint


  • The role requires international travel, approximately around 10%
  • You will be reporting to the IT Quality and Compliance Manager

Please be aware that by applying for this role, you are giving Arjo permission to store your information.

Required skills

  • Information Technology
  • Quality Assurance
  • Quality Control
  • Software Development
  • CSV

Reference: 34638554

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