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CSV Validation Engineer
Katalyst Healthcares & Life Sciences
- 🇬🇧 United Kingdom | 🇺🇸 United States
- On-site
- Manager or above
- 5 hours ago
- GxP
- CAPA
- GMP
5 hours ago
We are seeking an experienced CSV (Computer System Validation) Engineer to support the validation and compliance of GxP-regulated computerized systems in a regulated pharmaceutical, biotech, medical device, or similar environment. The CSV Engineer will be responsible for developing and executing risk-based validation strategies, preparing validation documentation, performing testing, managing deviations and CAPAs, and ensuring computerized systems meet intended-use, regulatory, quality, and data integrity requirements.
Roles and Responsibilities
- Develop and execute Computer System Validation (CSV) strategies, plans, protocols, test scripts, and validation reports.
- Perform and document risk assessments, system impact assessments, traceability assessments, and change control activities.
- Support validation of GxP-regulated computerized systems in accordance with applicable regulatory requirements, industry standards, and company procedures.
- Execute and document validation test scripts, including identification and resolution of discrepancies and deviations.
- Support deviation investigations, root-cause analysis, CAPA, and corrective actions related to computerized systems.
- Ensure computerized systems comply with applicable FDA, GxP, GMP, 21 CFR Part 11, and data integrity requirements.
- Apply risk-based validation methodologies throughout the system lifecycle.
- Support system implementation, upgrades, remediation, periodic reviews, and decommissioning activities.
- Collaborate closely with Quality Assurance, IT, Engineering, Manufacturing, Validation, and business stakeholders to ensure systems meet intended-use and compliance requirements.
- Review system documentation, test evidence, configuration records, and other validation deliverables for completeness and compliance.
- Support audit and inspection readiness by providing validation documentation, test evidence, and compliance records.
- Identify validation gaps and support remediation activities to maintain the validated state of computerized systems.
- Bachelor's degree in computer science, Information Technology, Engineering, Life Sciences, Pharmaceutical Sciences, or a related technical field.
- A master's degree or relevant professional certification in validation, quality, compliance, or a related discipline is a plus.
- 3+ years of experience in Computer System Validation (CSV), IT validation, or a closely related validation/compliance role within a regulated environment.
- Experience working in pharmaceutical, biotechnology, medical device, healthcare, or other GxP-regulated industries.
- Hands-on experience developing and executing validation documentation, protocols, and test scripts.
CSV Validation Engineer · Katalyst Healthcares & Life Sciences