Ingénieur Assurance Qualité Environnementale H/F
Core
Environmental Quality Assurance Engineer supporting sterile injectable production and R&D projects in cleanrooms and utilities.
Role type
Senior IC Environmental Quality Assurance Engineer
Builds
Sterile injectable aesthetic medicine products (hyaluronic acid)
Domain
Pharmaceutical manufacturing / Medical devices / Cleanroom operations
Deliverable
Production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Cleanroom (ZAC) operations, Utilities management, Cross-contamination control, Change Control, Risk assessment, Audit management, CAPA implementation, GMP/BPF knowledge, ISO 13485/14644/EN 17141 standards, LIMS data management
Preferred skills
Strategic project support, Protocol review, Training delivery, Internal/External audit coordination
Technologies
LIMS, MS Office suite
Responsibilities
Support strategic operational and R&D projects for cleanroom and utility standards; Participate in Change Control and technical reviews of protocols and QIQO reports; Liaise with production, CQEM, and CQS teams for project tracking; Draft Change Requests for control points in LIMS; Define cleaning strategies and cross-contamination prevention methods; Conduct training for cleanroom gowning; Lead environmental audits and corrective actions; Establish risk assessments for non-conformities in controlled zones and utilities; Implement CAPA for internal/external audits and non-conformities.
