Computer System Validation Technician

Bradford, GB
Chapel, GB
Dundee, GB
Edinburgh, GB
Home Working, GB
Sandwich, GB
About this position:

Do you want to be part of a business that genuinely values entrepreneurialism, innovation and individual accountability? We focus on our customers and are proud of the difference our technology makes. We partner with some of the biggest manufacturing companies in the world and our technical innovations are used to enhance well-known brands across multiple industries.

Job Purpose:

Reporting to the CSV Analyst and liaising with the IT and Quality Functions, across all sites the CSV (Computer Systems Validation) Technician is responsible for:

  • Assisting the validation of computerised systems in a GxP environment and the preparation of CSV documentation including Risk Assessments, Validation Plans, User Requirements Specifications, Qualification Test Protocols, Test Scripts, and Validation Reports
  • Monitor CSV activities within own area of accountability, to ensure quality and compliance with all legislation, regulations and standards
  • Manage relationships effectively with a wide range of internal and external individuals and bodies during any CSV assignment
  • Ensure information produced by CSV activities is available to and applied correctly in any relevant, related activities such as business change management
  • Identify and implement the procedures, tools and techniques applicable to CSV activities to Maintain / Track / Improve computer system compliance within the company
  • Provide CSV expertise and risk analysis in order to agree the validation approach, if any, for projects and change control requests

This job contributes to organisational success by:

  • Work with internal and external sponsors and stakeholders for a CSV assignment
  • Apply best practice in CSV and lessons learned from prior experience in CSV assignments
  • Use the procedures, tools and techniques for undertaking CSV as directed by the CSV Analyst to monitor the alignment of CSV activities with all relevant legislation, regulations and standards
  • Identify opportunities to improve the quality and effectiveness of CSV activities
  • Identify and select the actions to be taken in the event of the deliverables of CSV being incorrect, incomplete or inadequate
  • Monitor and report on compliance with all relevant legislation, regulations and standards relating to CSV and the effectiveness and quality of CSV activities
  • Manage the alignment of CSV activities with all relevant legislation, regulations and standards
  • Conduct CSV assignments that may contain complex, non-routine and strategic issues that need to be addressed
  • Communicate effectively and in a timely manner with sponsors, stakeholders and external bodies on all aspects of CSV activities

Job Requirements:

  • An undergraduate degree or recognised technical diploma in a Computer Science or Life Science related field, or relevant professional experience
  • Excellent understanding of system compliance regulatory requirements and guidelines
  • At least 2 years’ experience of Computer System Validation with regulated industries to recognised standards
  • Working knowledge of systems such as Laboratory Systems, Document Management Systems Proficiency in both verbal and written communications and possess a high degree of personal integrity and interpersonal skills
  • Leadership and teamwork skills
  • Strong problem solving, analytical, technical acumen and organisational skills
Posted 30+ Days Ago
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Job ID: 4026