The Life Science Career Network
CTC are specialised industry experts who can help companies source the best talent and provide reliable HR and consulting services, support varied candidates in finding promising career opportunities and offer the latest in skill development training programmes.
CSV Engineer Qualification and Validation
Our client, a world-leading pharmaceutical company focused on biopharmaceuticals, is looking for a CSV Engineer for a 12-month contract (with possibility for extension) based in Vaud area, Switzerland.
- Create, update or review validation documents including Validation plan, testing plan, test scripts for IQ, OQ and PQ and drive execution of verification tests in collaboration with the Project Team.
- Ensure validation tests performed at core template level are leveraged for site deployment.
- Compile validation summary reports and ensure all deviations from validation test scripts are properly documented, a rigorous follow up plan is in place to close these deviations properly within defined project timeline.
- Participate in site compliance enhancement.
- Write, review, and approve validation documents (examples include plans, specifications, risk analysis, protocols, test scripts, validation reports, deviations, SOPs…).
- Understand and systematically comply with Annex 11, 21 CFR Part 11, GAMP 5 and cGMP requirements.
- Excellent written communication and good communication skills to capture business needs, address them through comprehensive validation documentation and SOPs supporting correct use of Computerized Systems.
Qualifications and Experience:
- Relevant working/residency permit or Swiss/EU-Citizenship required
- 5-10 years’ experience in CSV and Equipment Qualification
- General Engineer Degree – speciality in Design and Industrialization of mechanical systems
- Fluent in English and French
Would you like to learn more about CTC and the opportunity outlined? Please, get in contact with us: you may either use the 'apply now' button, or write an email to us, or reach out to us on the phone.