Sterility Assurance Lead - Aseptic Excellence, Hybrid

Entourage; Roma; Híbrido; EUR 33.000 - 41.000; Jornada completa

Descripción de la vacante

Entourage is seeking a Sterility Assurance Expert with 6+ years of experience in sterile pharmaceutical or biotech manufacturing to support Life Sciences clients in the Lazio region (Rome area). The role is hybrid and involves defining CCS, leading aseptic processing, and overseeing sterilization validation.

The candidate brings deep knowledge of EU GMP Annex 1, regulatory expectations, and CAPA-driven quality improvement, along with strong collaboration across Manufacturing, QA, and Validation

Formación

• At least 6 years of experience in Sterility Assurance, Microbiology QA or aseptic manufacturing in a GMP environment.
• In-depth knowledge of EU GMP Annex 1 (2022) and related guidance (FDA, PIC/S, USP).
• Contamination Control Strategy (CCS) design and gap assessment.
• Sterilization validation: moist heat, dry heat, VHP/gas, sterile filtration.
• Aseptic process simulation (media fill) design and evaluation.
• Environmental monitoring, classification and qualification (ISO 14644).
• Root cause analysis and CAPA in microbiology/sterility.
• GMP documentation: SOPs, protocols and reports.
• Native Italian speaker.

Responsabilidades

• Define, implement and maintain the site CCS in line with EU GMP Annex 1.
• Act as Sterility Assurance SME for aseptic processing and terminal sterilization.
• Oversee sterilization and depyrogenation validation (steam, dry heat, VHP, filtration).
• Lead aseptic process simulations (media fills) and review results.
• Support environmental and utilities monitoring programs and trend analysis.
• Investigate sterility-related deviations and OOS/OOL results, define CAPA.
• Review cleaning, disinfection, gowning practices; support regulatory inspections.

Conocimientos

Sterility Assurance

GMP compliance

EU GMP Annex 1 knowledge

Aseptic processing

Environmental monitoring

CAPA

Quality Risk Management

GMP documentation

Fluent English

Italian (native)

Educación

Degree in Microbiology/Biology/Biotechnology/Pharmacy

Descripción del empleo

Entourage is seeking a Sterility Assurance Expert with 6+ years of experience in sterile pharmaceutical or biotech manufacturing to support Life Sciences clients in the Lazio region (Rome area). The role is hybrid and involves defining CCS, leading aseptic processing, and overseeing sterilization validation.

The candidate brings deep knowledge of EU GMP Annex 1, regulatory expectations, and CAPA-driven quality improvement, along with strong collaboration across Manufacturing, QA, and Validation