We are seeking a skilled CSV Engineer to join our company in Basel on an initial 6-month contract. The ideal candidate will have a robust background in Computer System Validation (CSV) and Automated systems within the pharmaceutical and biotechnology industries, 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.