Computerized System Validation Engineer

vor 3 Wochen

Lausanne greater area, Schweiz Capgemini Suisse SA Vollzeit
About Us

At Capgemini Engineering Switzerland we value excellence, diligence, responsibility, dynamism and innovation. We offer a diverse workplace and would like to invite you to be part of our success story where we provide training, tools and foundations for your professional and personal growth. We are looking for an experienced (Computerized System Validation) CSV Engineer.


Job description
•    Develop and execute CSV protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for 
     computerized systems.
•    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.

 

Your Profile
•    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


Benefits
•    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 


We look forward to receiving your application. Capgemini Engineering only accepts direct applications (no recruitment agencies). Due to Swiss regulations we only consider Swiss or EU/EFTA applicants or applicants with a valid work permit.
 

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