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Shape compliant digital systems across the life sciences industry.
RRxCo is seeking an experienced Computer Systems Validation (CSV) Consultant to support pharmaceutical, biotechnology, and medical device organisations ranging from innovative start-ups to global enterprises.
This is a client-facing role focused on systems validation, data integrity, and regulated technology environments, not engineering.
Working across a variety of client projects, you will partner with quality, regulatory, IT, and operational teams to ensure computerised systems remain compliant, validated, and inspection-ready. You will be supported by our Head of Software Validation and work closely with our Head of Client Solutions to deliver practical, risk-based solutions that add genuine business value.
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Key Responsibilities
- Lead and support CSV activities across the system validation lifecycle.
- Develop and review validation documentation, including URS, risk assessments, protocols, traceability matrices, and reports.
- Provide guidance on GxP, Data Integrity, and regulatory compliance requirements.
- Support system implementations, upgrades, migrations, and remediation projects.
- Conduct gap assessments and help clients improve validation and compliance frameworks.
- Build strong relationships with stakeholders across client organisations.
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What We're Looking For
- Proven experience in Computer Systems Validation within the pharmaceutical, biotechnology, or medical device sectors.
- Strong understanding of GxP, Data Integrity, Annex 11, and 21 CFR Part 11 requirements.
- Experience validating GxP-regulated software platforms (eQMS, LMS, ERP, LIMS, MES, CRM or similar).
- Excellent communication and consultancy skills.
- Ability to work independently in a fully remote environment.
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