Beschreibung
Our client, who is one of the leading Contract Manufacturing companies globally, is currently looking for a CSV Engineer to support the team with their day-to-day validation activities and to qualify the systems they have set up for the efficient running of production.
Main responsibilities:
- Responsible for Computerized System Validation (CSV) deliverables for new Large Scale
- facilities, equipment, and utilities related to the GMP manufacturing of biologics
- Representative of Quality in the CAPEX project organization in regard to CSV
- Reviewing and releasing quality-related CSV project deliverables
- Ensure CSV deliverables meet Global procedures, regulatory requirements, and policies
- Being a Subject Matter Expert and providing guidance and recommendations to internal or external project stakeholders
Key requirements:
- Bachelor's or Master's degree in Computer Science, Engineering, Life Science, or a related field
- Hands-on experience in CSV, Data Integrity, and related Guidelines (ie 21 CFR Part 11, EU GMP Annex 11, GAMP5)
- Experience in interaction with all kinds of interfaces within the organization and with regulatory agencies (Swissmedic, FDA, etc.)
- Working knowledge of MES (Syncade) and DCS (DeltaV) is required
- Fluency in English, and German would be an advantage
Job Title: CSV Expert
Location: Vaud, Switzerland
Job Type: Contract
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