Blackfield are supporting a global pharmaceutical client seeking a CSV Engineer on a rolling 12-month contract/freelance basis.
In this role, you will lead computerised system validation (CSV) for process equipment, facilities, and MES, ensuring compliance and driving process improvements.
Role responsibilities: Develop and execute CSV documentation for new systems and upgrades
Manage deviations, change controls (GEP & GMP), and CAPAs
Coordinate CSV activities with internal teams and external vendors
Present CSV documentation during audits and regulatory inspections
Align CSV strategy with QA and biologics operations
Key requirements: Degree or equivalent in a technical discipline
Proven CSV experience in a regulated pharmaceutical/biotech environment
Strong knowledge of Microsoft Office & DeltaV (experience with Kneat, Comos, TrackWise, and SAP is a plus)
Seniority level Associate
Employment type Contract
Job function Quality Assurance, Engineering, and Manufacturing
Industries Pharmaceutical Manufacturing, Biotechnology Research, and Chemical Manufacturing
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