We are seeking a skilled CSV Engineer to join our team on a 6-month initial contract in Basel. The ideal candidate will have a robust background in Computer System Validation (CSV) and Automated systems within the pharmaceutical and biotechnology industries. This role involves leading validation projects and ensuring compliance with regulatory standards.
Key Responsibilities:
- Lead and manage CSV projects for IT and GMP operations applications and systems.
- Configure and initially validate software systems.
- Validate and integrate SCADA - PLC systems, including hardware and software updates.
- Author and standardize procedures for CSV, data migration, and lifecycle management.
- Conduct end-to-end data integrity assessments and standardize change management processes.
- Ensure continuous quality assurance of corporate systems and compliance with regulatory standards.
Qualifications:
- Bachelor's degree in Engineering, Computer Science, or a related field.
- 5+ years of experience in CSV within the pharmaceutical or biotechnology industries.
- Strong knowledge of SCADA and PLC systems.
- Experience in Quality Assurance within CSV is a plus.
- Proven track record of leading validation projects and managing IT infrastructure.
- Excellent technical writing skills and experience authoring validation documentation.
- Familiarity with regulatory requirements and standards.
- Excellent communication and interpersonal skills.
- Fluent in English.
Why Join Us:
- Work in Basel, a hub of innovation in the pharmaceutical industry.
- Competitive salary and benefits.
- Opportunity to work on cutting-edge projects.
- Collaborative and dynamic work environment.
