Senior Computer Systems Validation Engineer
A worldwide biotechnology company situated in Switzerland is looking for a Senior Computer Systems Validation Engineer (CSV) to join them. The company specialises in neurological conditions and puts a great emphasis on teamwork and delivering biological products.
- Oversee and perform computer system validation activities at the Solothurn site and ensures the approach and execution aligns to directives and procedures.
- Provide input on improvement of testing documentation.
- Support the implementation and adoption of the global CSV program and remediation.
- Support data integrity implementation and remediation for systems within CSV program.
- Participate in audits and continuous improvement efforts related to CSV program.
- Support the organization to achieve all CSV site and corporate goals.
Skills and Requirements
- Bachelor's Degree (BS) in Engineering/Sciences or equivalent.
- 10 to 15 years related experience and/or training; or an equivalent combination of education and experience.
- Ability to complete tasks with limited oversight
- Understanding of regulations governing computer systems such as FDA's 21, EMA's and Annex 11
- Understanding of modern and risk- based validation executions
- Background in Lifesciences and/or Pharma/Biotech industries (or understanding of bioprocessing and support processes)
- Direct experience with IT and MFG automation systems supporting GMP manufacturing
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Caleb Mensah at +44 203 854 1080 or upload your CV on our website - www.proclinical.com/send-cv
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.