Computer System Validation (CSV) Engineer
- Contract
Date Posted: January 29, 2026
Job Description
The CSV Engineer supports validation activities for computerized systems used in a regulated pharmaceutical manufacturing and quality environment. This role is responsible for authoring, reviewing, and approving CSV documentation to ensure systems comply with FDA and global requirements, support data integrity, and remain inspection ready throughout the system lifecycle.
Key Responsibilities
- Author CSV validation protocols and deliverables, including IQ, OQ, PQ, and risk-based validation documentation
- Perform pre-execution review of validation protocols to ensure compliance with internal procedures, GxP requirements, and regulatory expectations
- Conduct post-execution review of validation documentation to verify proper execution, traceability, and deviation resolution
- Approve validation protocols, reports, and supporting documentation as a designated CSV approver
- Ensure computerized systems comply with 21 CFR Part 11, data integrity principles, and applicable FDA and global regulatory guidance
- Support validation activities for pharmaceutical manufacturing, laboratory, and quality systems
- Collaborate with Quality, IT, Automation, and Business stakeholders throughout the validation lifecycle
- Assess validation impact for system changes, upgrades, periodic reviews, and decommissioning activities
- Support regulatory inspections and internal audits by providing validation documentation and technical responses
- Maintain accurate and compliant records within document management and validation tracking systems
Required Qualifications and Skills
- Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline, or equivalent experience Experience performing Computer System Validation within a pharmaceutical GxP environment
- Demonstrated experience authoring and reviewing CSV protocols and reports
- Strong understanding of system lifecycle validation, risk-based approaches, and data integrity requirements
- Working knowledge of FDA regulations and guidance including 21 CFR Part 11 and GAMP 5
- Validation protocol authoring and document review
- Regulatory compliance and inspection readiness
- Risk assessment and deviation evaluation
- Cross-functional collaboration in regulated environments
If you are keen to grow your career with this job, apply with us and send us your resume now. All shortlisted candidates will be contacted shortly.
Reference no.: 122-4948-2918-NW
Registration no.: 968446516E