Qualification & Validation Technician / Engineer (M/F)

Qualification & Validation Technician (M/F)

Temporary assignment of 6 months

Start : As soon as possible

Location : Geneva

Sector : Pharmaceutical industry

As part of a project to reorganise R&D facilities and implement a new production line, our partner is looking for an experienced Qualification & Validation Technician to strengthen the teams.

Your tasks

• Write and execute qualification protocols (IQ, OQ, PQ).
• Participate in the qualification and requalification of clean rooms.
• Contribute to the qualification of equipment and sterile manufacturing lines, particularly in an aseptic environment.
• Participate in validation/revalidation activities of sterilisation processes (autoclaves, associated equipment).
• Analyse qualification and validation results, handle deviations and contribute to the implementation of corrective actions (CAPA).
• Participate in risk analyses associated with microbiological monitoring of facilities.
• Interact with suppliers and project teams in an international context.
• Contribute to the qualification activities of automated and computerised systems, in compliance with applicable regulatory requirements.

Profile sought

• Proven experience in qualification/validation of clean rooms in a GMP environment.
• Experience in qualification and validation of equipment, systems or sterile manufacturing processes, ideally aseptic.
• Good knowledge of sterilisation equipment such as autoclaves.
• Experience in barrier technologies (RABS or isolators) or in their qualification.
• Experience in risk analysis applied to microbiological monitoring.
• Knowledge of GMP requirements and pharmaceutical qualification/validation practices.
• Experience in CSV (Computer System Validation) and knowledge of 21 CFR Part 11 requirements is an advantage.

Skills

• Fluent French.
• Professional English essential (numerous interactions with suppliers and international partners).
• Rigour, autonomy and team spirit.
• Good analytical and problem-solving skills.
• Proactive attitude and sense of responsibility.