CSV Engineer

About the role

The CSV Engineer will lead the validation activities for new information system projects within a regulated pharma/biotech environment. You will ensure that all computerized systems meet cGMP, 21 CFR Part 11 and EU Annex 11 requirements while supporting cross‑functional teams.

Key responsibilities

• Manage, coordinate and execute validation deliverables for new IS projects.
• Prepare Validation/Qualification Plans, Risk Assessments, User Requirement Specifications, Traceability Matrices, and testing protocols (IQ, OQ, PQ).
• Oversee data migration, SOPs, change controls and ensure full regulatory compliance.
• Provide compliance leadership and guidance on GxP regulations, including 21 CFR Parts 11, 820 and EU GMP Annex 11.
• Support resolution of project deviations and participate in multidisciplinary project teams.
• Conduct validation training for project teams and ensure the Technical Services Manager is consulted on all deliverables.

Required profile

• Bachelor’s degree with at least 3 years of CSV experience in pharma or biotech.
• Strong knowledge of cGMP regulations, computerized system life‑cycle, and GxP requirements.
• Ability to work independently, adapt to changing priorities and make decisions.
• Excellent written and verbal communication skills and proven leadership in cross‑functional environments.

Required skills

• Experience with ERP, MES and LIMS platforms.
• Familiarity with Quality Systems and validation documentation.
• Proficiency with PC tools and automation systems.