Chargé(e) de validation - h/f
Core
Conducting process validations for medical device packaging and aseptic pharmaceutical distribution in cleanroom environments, ensuring compliance with regulatory standards.
Role type
Process Validation Engineer (Medical Devices/Pharma)
Builds
Validated processes for medical packaging and aseptic pharmaceutical products
Domain
Medical devices and pharmaceutical industry
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process validation, protocol and report writing (QI, QO, QP), change control management, project management for industrialization, cleanroom operations, software validation (MES), knowledge of ISO 13485, English document transcription
Preferred skills
Knowledge of ISO 9001, BPF, Pharmacopoeia, VBA/Excel, continuous improvement methodologies
Technologies
MES, Excel (VBA, TCD)
Responsibilities
Perform cleaning and packaging process validations in cleanroom; Write qualification protocols and reports; Participate in software validation; Manage change controls and action plans; Support new client integration and validation; Lead product design/industrialization validation projects
Seniority
Mid-level, hands-on IC
