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Computer Systems Validation (CSV) Engineer - Maternity Cover 12 month contract
Computer Systems Validation (CSV) Engineer
Department: Quality / ValidationJob Title: Computer Systems Validation (CSV) Engineer
Role Overview
Catalyx is seeking a Computer Systems Validation (CSV) Engineer to support the validation of software applications and computerised systems used in regulated pharmaceutical, biotechnology and medical device environments.
The successful candidate will be responsible for authoring, reviewing and executing validation documentation and test protocols, ensuring software solutions meet defined requirements, regulatory expectations and quality standards.
The role requires strong technical writing skills, practical CSV experience and the ability to collaborate with Software Development, Testing, Operations and Quality Assurance teams throughout the Software Development Lifecycle (SDLC).
Key Responsibilities
Computer Systems Validation and Documentation
Prepare, review and execute validation documentation, including Validation Plans, Installation Qualification (IQ), Operational Qualification (OQ), Acceptance Test (AT) protocols and Validation Summary Reports.
Independently author clear, accurate and technically sound validation protocols and test scripts, including test steps, expected results and acceptance criteria.
Review software requirements and functional specifications to ensure appropriate validation coverage.
Develop and maintain Requirements Traceability Matrices (RTMs).
Execute validation protocols, document results and supporting evidence, and manage discrepancies and deviations.
Apply risk-based validation principles in accordance with GAMP 5 and applicable regulatory requirements.
Regulatory Compliance and SDLC Support
Ensure validation activities comply with applicable GxP requirements, FDA 21 CFR Part 11, EU GMP Annex 11 and internal quality procedures.
Apply Good Documentation Practices (GDP) and ALCOA+ data integrity principles.
Collaborate with Development, Testing and Quality Assurance teams to investigate and resolve issues identified during validation.
Support software change control, impact assessments and release activities.
Maintain accurate and traceable validation records to support customer audits and regulatory inspections.
Contribute to the continual improvement of validation processes, templates and documentation standards.
Qualifications and Experience
Essential Requirements
Degree in Computer Science, Engineering, Information Technology, Science or a related technical discipline.
Demonstrated experience in Computer Systems Validation (CSV) within a regulated GxP environment.
Proven ability to independently author validation protocols, test scripts and validation reports.
Strong technical writing skills, with excellent attention to detail and documentation accuracy.
Working knowledge of GAMP 5, FDA 21 CFR Part 11, EU GMP Annex 11 and risk-based validation principles.
Experience reviewing software requirements and functional specifications and developing requirements traceability documentation.
Understanding of Good Documentation Practices (GDP), data integrity principles and deviation management.
Strong communication, analytical and problem-solving skills.
Desirable Requirements
Experience validating software used in pharmaceutical manufacturing, automation or machine vision systems.
Familiarity with Computer Software Assurance (CSA) principles.
Experience working within an Agile software development environment.
Familiarity with software change control, configuration management and release management processes.
Experience using software testing or test management tools.