pAt 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. /ph3Your role /h3pWe 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. /pulliYou define, implement and maintain the site CCS in line with EU GMP Annex 1. /liliYou act as Sterility Assurance SME for aseptic processing and terminal sterilization. /liliYou oversee sterilization and depyrogenation validation (steam, dry heat, VHP, filtration). /liliYou lead aseptic process simulations (media fills) and review their results. /liliYou support environmental and utilities monitoring programs (cleanrooms, WFI, clean steam, compressed gases) and trend analysis. /liliYou investigate sterility-related deviations, OOS/OOL results and excursions, and define CAPA. /liliYou review cleaning and disinfection programs and aseptic behavior and gowning practices. /liliYou support regulatory inspections and audits on sterility assurance topics.



/li /ulh3What you bring /h3h3Hard skills /h3ulliAt least 6 years of experience in Sterility Assurance, Microbiology QA or aseptic manufacturing in a GMP environment. /liliIn-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). /liliContamination Control Strategy (CCS) design and gap assessment. /liliSterilization validation: moist heat, dry heat, VHP/gas, sterile filtration (filter validation, PUPSIT). /liliAseptic process simulation (media fill) design and evaluation. /liliEnvironmental monitoring, cleanroom classification and qualification (ISO 14644), HVAC and barrier technologies (RABS, isolators). /liliMicrobiological investigations, root cause analysis and CAPA. /liliQuality Risk Management (ICH Q9, FMEA, HACCP) applied to contamination control. /liliGMP documentation: writing and reviewing SOPs, protocols and reports. /liliNative Italian speaker. /li /ulh3Soft skills /h3ulliCross-functional collaboration with Manufacturing, QA, QC Microbiology, Engineering and Validation. /liliAbility to act as a reference SME and train operators on aseptic practices. /liliAnalytical thinking and attention to detail. /liliClear communication, including during inspections. /liliFluent English. /li /ulh3Preferred qualifications /h3ulliDegree in Microbiology, Biology, Biotechnology, Pharmacy, Chemistry or Engineering. /liliExperience in regulatory inspections (AIFA, EMA, FDA) on sterile products. /liliExperience with Annex 1 remediation projects. /li /ulh3Location: /h3pLazio region (Rome area), hybrid /ph3Salary: /h3pStarting from €37,000 gross per year (RAL), commensurate with experience. /ph3Your contact: /h3pDelia Farioli, Sales Manager /p #J-18808-Ljbffr

📌 Sterility Assurance Specialist (Roma)
🏢 Entourage
📍 Roma