CSV AUTOMATION ENGINEER (M / F)YOUR ROLE : - Represent the department at project launch and follow-up meetings- Drawing up, drafting, updating and archiving qualification documents in accordance with current procedures : validation plans, IQ, OQ, PQ and Traceability matrices- Plan, organise and conduct IQ / OQ / PQ / Hypercare qualification tests.
- Collaborating with the global departments and other sites involved in the initial qualifications and the various modifications.
- Drafting and managing deviations in accordance with the system in place during initial qualifications.- Maintaining the service's performance indicators.
- Taking an active part in improving the qualification processes in place, with a view to improving efficiency and reducing costs.
The permanent position is based in the canton of Geneva
YOUR PROFILE : To join the EFOR Group as a CSV Engineer Consultant (M / F) : - You have a bachelor's / master's degree (EPF, HES, university, Bac +5) in engineering, information systems or equivalent.
- You have a previous experience in the field of information systems (ERP, GPAO, MES, LIMS, etc.) or have collaborated in their implementation.
- You have participated in the validation of systems and are familiar with the regulatory requirements and guidelines in force in the pharmaceutical sector (GLP, GMP, ICH, 21 CFR part 11, etc.
You have a previous experience with these Equipments : CAP washing machine, autoclave, filling line, freeze-dryer, sterilisation tunnel, capper, data matrix engraving system, COP / SOP.
- Fluency in office automation tools, spreadsheets, Mango (or equivalent system), Trackwise.- You speak fluently French and English