{"id":2922043,"url":"https://alion.io/job/agc-biologics-process-validation-scientist","title":"Process Validation Scientist","company":{"id":1878645,"name":"AGC Biologics","domain":"agcbio.com","url":"https://alion.io/company/agcbio","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":null},"role":"Science & Research","role_family":"Science & Research","seniority":null,"employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Milan, Italy"],"countries":["IT"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":36000,"max_usd":89000,"period":"year","method":"role_country_seniority_unknown","sample_n":27},"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-10-20T12:26:58Z","employer_posted_date":"2026-10-20","last_verified_at":"2026-10-29T08:24:16Z","board_verified":true,"closed_at":null,"days_open":9,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":9},"description":"Attività principali:\nStesura e revisione documenti GMP per Process Validation, quali PPQ Master Plan, PPQ protocol e report, protocolli e report per studi supportivi alla validazione, gap e impact assessment report, analisi del rischio e identificazione parametri critici di processo, valutazione specifiche di processo e analitiche, raccolta e analisi dati.\nCollaborazione con le unità di GMP manufacturing, QA e QC per revisione dei documenti MBR, PTS e sampling plan.\nSupporto nella revisione di dossier regolatori e assessment degli stessi da parte degli enti regolatori.\nSupporto a MSAT Compliance nella valutazione di change control, CAPA e deviazioni.\nInterazione e discussione tecnica con i Clienti dell’azienda.\nSupporto nelle ispezioni da parte dei Clienti e degli entri regolatori.\nRequisiti:\nLaurea in Biotecnologie/ CTF o similari\nForte attitudine al problem solving e capacità di lavorare in team\nBuona capacità di analisi critica dei dati e dei processi\nFlessibilità e adattamento nei cambi di strategia di un progetto\nBuona conoscenza dell’inglese parlato e scritto\nBuona competenza di scrittura documenti \nSalary range: 35.000 - 38.000\nWho We Are \nAGC Biologics is a global Contract Development and Manufacturing Organization with a strong presence in Italy. From our Milan site, we develop and manufacture life-changing advanced biologics for some of the world’s most innovative pharmaceutical companies. Together with our team members across Europe, the U.S., and Japan, we deliver development and manufacturing of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells therapies. 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