CSV Consultant

Apotech is a Life Science Management Consultancy, delivering outsourced services in Quality and Regulatory Affairs. After three successful years, we are in a growing phase with big ambitions! Fundamental to the business is to continue to create an organisation where employees are excited to come to work, are proud of what we do & who we are and push the boundaries of social responsibilities. We are now seeking a GMP Auditor to join our amazing team. 

Job Title: CSV Consultant 

Location: Flexible/Remote or willing to travel onsite within the EU 

Position Overview:

We are seeking a highly skilled and experienced freelance CSV (Computer System Validation) Consultant to join our team. The ideal candidate will have a strong background in regulatory compliance, quality assurance, and information technology, with expertise in CSV principles and practices. As a freelance consultant, you will be responsible for providing guidance, support, and expertise to clients in validating computerised systems used in regulated industries, such as pharmaceuticals, biotechnology, medical devices, and healthcare.


  • Collaborate with clients to develop and execute CSV strategies, plans, and protocols for computerised systems by regulatory requirements (e.g., FDA, EMA, MHRA) and industry best practices.
  • Conduct risk assessments and gap analyses to identify validation requirements, critical systems, and potential areas of non-compliance.
  • Guide the selection, implementation, and configuration of software applications, IT infrastructure, and cloud-based solutions to ensure compliance with CSV requirements.
  • Review system requirements, user requirements, functional specifications, and design documents to ensure completeness, accuracy, and traceability throughout the validation lifecycle.
  • Develop and execute validation protocols, including IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification), and validation test scripts, to verify system functionality and performance.
  • Perform validation activities, such as protocol execution, test execution, and documentation of test results, deviations, and discrepancies, in compliance with established procedures and timelines.
  • Prepare validation documentation, including validation plans, risk assessments, traceability matrices, validation summary reports, and compliance documentation, to support regulatory submissions and audits.
  • Provide training and guidance to client personnel on CSV principles, validation methodologies, and best practices for maintaining compliant computerized systems.


  • Bachelor’s degree in computer science, engineering, life sciences, or a related field. Advanced degree (e.g., master’s or Ph.D.) preferred.
  • Extensive experience in CSV and computerized system validation, with a minimum of 5 years working in regulated industries, such as pharmaceuticals, biotechnology, medical devices, or healthcare.
  • In-depth knowledge of regulatory requirements for CSV, including FDA 21 CFR Part 11, EU GMP Annex 11, GAMP 5, and other relevant guidelines and standards.

CSV Consultant

Temp / Perm:  Temp

Service Area: MedTech / IVD

On Site / Remote: Remote