CSV Engineer

vor 4 Wochen

Lausanne, Schweiz Blackfield Associates Vollzeit

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:
  1. Develop and execute CSV documentation for new systems and upgrades
  2. Manage deviations, change controls (GEP & GMP), and CAPAs
  3. Coordinate CSV activities with internal teams and external vendors
  4. Present CSV documentation during audits and regulatory inspections
  5. Align CSV strategy with QA and biologics operations
Key requirements:
  1. Degree or equivalent in a technical discipline
  2. Proven CSV experience in a regulated pharmaceutical/biotech environment
  3. 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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