Sterility Assurance Specialist

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

At Entourage, we believe work has more value when it respects people, company goals and individual aspirations. We see these three as one starting point for every project, every collaboration and every decision. We are a life sciences consulting firm built around people: the people on our team and the clients we support every day. Five values shape how we work: integrity, openness, ownership, excellence and collaboration. We don't just fill positions. We look for professionals to build something with, in an environment where the quality of work and the quality of life go together. We are convinced that a better working experience, inside and outside the company, is how we make a real difference.

Your role

We are looking for a Sterility Assurance Expert with at least 6 years of experience in sterile pharmaceutical or biotech manufacturing to support our Life Sciences clients.

• You define, implement and maintain the site CCS in line with EU GMP Annex 1.
• You act as Sterility Assurance SME for aseptic processing and terminal sterilization.
• You oversee sterilization and depyrogenation validation (steam, dry heat, VHP, filtration).
• You lead aseptic process simulations (media fills) and review their results.
• You support environmental and utilities monitoring programs (cleanrooms, WFI, clean steam, compressed gases) and trend analysis.
• You investigate sterility-related deviations, OOS/OOL results and excursions, and define CAPA.
• You review cleaning and disinfection programs and aseptic behavior and gowning practices.
• You support regulatory inspections and audits on sterility assurance topics.

What you bring

Hard skills

• 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), FDA Guidance on Sterile Drug Products Produced by Aseptic Processing, PIC/S and USP/Ph. Eur. chapters (for example <71>, <1116>, <1211>, 5.1.1).
• Contamination Control Strategy (CCS) design and gap assessment.
• Sterilization validation: moist heat, dry heat, VHP/gas, sterile filtration (filter validation, PUPSIT).
• Aseptic process simulation (media fill) design and evaluation.
• Environmental monitoring, cleanroom classification and qualification (ISO 14644), HVAC and barrier technologies (RABS, isolators).
• Microbiological investigations, root cause analysis and CAPA.
• Quality Risk Management (ICH Q9, FMEA, HACCP) applied to contamination control.
• GMP documentation: writing and reviewing SOPs, protocols and reports.
• Native Italian speaker.

Soft skills

• Cross-functional collaboration with Manufacturing, QA, QC Microbiology, Engineering and Validation.
• Ability to act as a reference SME and train operators on aseptic practices.
• Analytical thinking and attention to detail.
• Clear communication, including during inspections.
• Fluent English.

Preferred qualifications

• Degree in Microbiology, Biology, Biotechnology, Pharmacy, Chemistry or Engineering.
• Experience in regulatory inspections (AIFA, EMA, FDA) on sterile products.
• Experience with Annex 1 remediation projects.

Location:

Lazio region (Rome area), hybrid

Salary:

Starting from €37,000 gross per year (RAL), commensurate with experience.

Your contact:

Delia Farioli, Sales Manager