Job description
About the Opportunity:
Our client, a leading international organisation within the medical technology and life sciences sector is seeking an experienced CSV (Computer System Validation) Consultant to support a series of critical digital and operational projects. Working as part of a cross-functional, multi-national team, this role offers the chance to contribute to meaningful healthcare initiatives in a highly regulated environment.
This is a 100% fully remote position with occassional site visits, for an initial 12 month contract.
Key Responsibilities:
Develop, review, and manage validation documentation in accordance with relevant GxP, ISO, and regulatory guidelines (including 21 CFR Part 11 and EU Annex 11).
Collaborate with business, IT, and quality stakeholders to define and execute validation strategies for new and existing computerised systems.
Perform risk assessments, gap analyses, and validation planning for a range of system implementations, upgrades, and migrations.
Provide subject matter expertise in audits and inspections, ensuring systems are maintained in a validated, compliant state.
Stay informed on current regulatory trends and contribute to continuous improvement of validation processes.
Candidate Profile:
Demonstrated experience in Computer System Validation within a life sciences, medical device, or pharmaceutical setting.
Solid understanding of international regulatory requirements.
Experience with validation of various systems such as ERP, LIMS, QMS, document management, and clinical systems is an advantage.
Strong communication and documentation skills, with the ability to manage diverse stakeholder expectations across regions.
Flexible, proactive, and comfortable working within a matrixed, global organisation.
Desirable:
Familiarity with Cloud/SaaS validation frameworks.
Experience supporting validation activities for medical technology or diagnostics systems.
Why Join?
This is an opportunity to work alongside expert teams within a respected, internationally operating organisation, delivering impactful projects that support patient care and healthcare innovation worldwide.
This is a 100% fully remote position with occassional site visits, for an initial 12 month contract.
Application Process:
If you are interested in this freelance contract position, please select APPLY to send us an up to date copy of your CV.
