Validation Engineer

**Division**:GC Aesthetics

**Location**: Apt, France

**Job Title**:validation engineer

**Department**: Quality

**Responsible to**:Validation manager

**Purpose of Job (Summary)**

As part of the installation and/or modification of equipment, systems, processes on the Apt site, and in compliance with the Good Practices in force, the permanent missions of the Qualification / Validation Engineer are as follows:

- Management of qualification / validation activities related to projects
- Management of periodic qualification / validation activities

**Key Responsibilities**
- Writes qualification protocols & reports (QI, QO, PQ, VP, NV...) for equipment, systems, and processes.
- Writes or participates in the development of risk or criticality analysis.
- Participates in the development of the qualification/validation strategy (validation plan, identification of the tests to be carried out, etc.).
- Executes qualification tests (QI, QO, QP, VP, NV...) of equipment, systems, and processes, with the management of qualification/validation non-conformities, respecting the rules of Good Documentary Practices when filling qualification/validation documents.
- Verifies protocols & reports provided by qualification/validation service providers.
- Writes change controls or participates in change control committees to monitor qualification/validation activities of the service and justify the need for qualification/validation according to the changes requested. Writes or updates the qualification/validation documents of the Quality Management System (procedures, operating methods, forms, etc.). Manages qualification/validation service providers during the performance of outsourced qualification/validation tests, from the establishment of HSE documents to the finalization of the service.
- Monitors the planning of qualification tests, as defined in the annual Validation Master Plan.
- Responds to non-conformities / CAPA concerning service activities or qualification/validation activities, by proposing and/or implementing quality, preventive or corrective actions.

**Qualifications/Experience**
- Higher education (BAC+5),
- Experience in qualification/validation of equipment, system or production facilities Knowledge of the following regulatory requirements: ISO 13485, Good Manufacturing Practices (Annex 15, Annex 11) / Eudralex Volume 4, 21 CFR Part 11, GAMP
- Proficiency in common office software: Microsoft Office (Word, Excel, PowerPoint) Knowledge of English (read, written, and spoken) Good writing skills
- Good interpersonal and communication skills,
- Analytical and synthetical mind Ability to plan activities and manage priorities
- Good knowledge of production equipment, systems or facilities
- Master risk analysis methods (FMECA type...) and problem-solving methods (PDCA, 5S, VSM...) Ability to work independently, with rigor