Computerized System Validation Engineer
Capgemini
- Lausanne
- Unbefristet
- Vollzeit
- Develop and execute CSV protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for
- Maintain comprehensive documentation for all CSV activities, ensuring adherence to regulatory standards and internal quality procedures.
- Collaborate with quality assurance teams to support regulatory inspections and audits.
- Implement and manage change control processes for computerized systems, conducting impact assessments for proposed changes.
- Ensure that changes to systems do not compromise data integrity or regulatory compliance.
- Support the full system lifecycle, from system design and implementation to periodic reviews and retirement.
- Bachelor's or Master's degree in relevant field, e.g., Computer Science, Engineering.
- Experience in CSV within the life science industry.
- Familiarity with regulatory requirements, including FDA, EMA, and other relevant guidelines.
- Strong understanding of operational processes in biopharmaceutical manufacturing.
- Excellent communication in English and French
- Between 30% and 70% remote work in agreement with your manager and client needs (40% for cross boarders due to tax regulation)
- Options to order ergonomically proven equipment (monitor & chair) for your home-office premises
- Support for trainings, formation upon agreement with the manager
- Contribution on gym subscription
- Trust-based managerial culture
- Team rituals and get togethers