CSV Engineer

About the role

The CSV Engineer will lead and coordinate computer system validation activities for new information system projects within a regulated pharmaceutical environment. This role ensures compliance with GxP regulations and drives validation deliverables from planning through execution.

Key responsibilities

• Manage, coordinate, develop and execute validation deliverables for new IS projects.
• Prepare Validation/Qualification Plans, Risk Assessments, User Requirement Specifications, Traceability Matrices, and conduct testing (IQ, OQ, PQ).
• Oversee data migration, SOP creation, and change control processes.
• Ensure computerized systems comply with regulatory requirements (21 CFR Part 11, 820, EU GMP Annex 11) and company policies.
• Provide compliance leadership, resolve project deviations, and guide teams on GxP requirements.
• Consult with Technical Services Manager on all validation deliverables and conduct validation training for project teams.

Required profile

• Bachelor’s degree with at least 3 years of CSV experience in pharma/biotech.
• Strong knowledge of cGMP regulations, computerized system development life‑cycle, and GxP compliance.
• Ability to work independently, adapt to changing priorities, and lead cross‑functional teams.
• Excellent written and verbal communication skills.

Required skills

• Experience with ERP, MES, LIMS, and Quality Systems.
• Knowledge of 21 CFR Part 11, EU GMP Annex 11, and cGMP.
• Proficiency in computerized system life‑cycle approaches and automation systems.
• Skills in data migration, validation planning, risk assessment, and testing (IQ, OQ, PQ).