Qualification & Validation Technician / Engineer

Qualification & Validation Technician (M/F)
Missio
Qualification & Validation
Qualification & Validation Technician (M/F)
6 month temporary mission
Start: As soon as possible
Location: Genève
Sector: Pharmaceutical industry
As part of a project to reorganize R&D facilities and set up a new production line, our partner is looking for an experienced Qualification & Validation Technician to strengthen the teams.
Your missions
Write and execute qualification protocols (IQ, OQ, PQ).
Participate in the qualification and requalification of cleanrooms.
Contribute to the qualification of equipment and sterile manufacturing lines, particularly in an aseptic environment.
Participate in the validation/revalidation activities of sterilization processes (autoclaves, associated equipment).
Analyze qualification and validation results, handle deviations, and contribute to the implementation of corrective actions (CAPA).
Participate in risk analyses associated with the microbiological monitoring of facilities.
Interact with suppliers and project teams in an international context.
Contribute to the qualification activities of automated and computerized systems, in compliance with applicable regulatory requirements.
Profile sought
Proven experience in qualification/validation of cleanrooms in a GMP environment.
Experience in qualification and validation of sterile manufacturing equipment, systems, or processes, ideally aseptic.
Good knowledge of sterilization 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/BPF requirements and pharmaceutical qualification/validation practices.
Experience in CSV (Computer System Validation) and knowledge of 21 CFR Part 11 requirements is an asset.
Skills
Fluent French.
Professional English indispensable (numerous interactions with international suppliers and partners).
Rigor, autonomy, and team spirit.
Good analytical and problem-solving skills.
Proactive and sense of responsibility. jpid8dc60c6jm jpit0836jm jpiy26jm