Attività principali: Stesura 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. Collaborazione con le unità di GMP manufacturing, QA e QC per revisione dei documenti MBR, PTS e sampling plan. Supporto nella revisione di dossier regolatori e assessment degli stessi da parte degli enti regolatori. Supporto a MSAT Compliance nella valutazione di change control, CAPA e deviazioni. Interazione e discussione tecnica con i Clienti dell’azienda. Supporto nelle ispezioni da parte dei Clienti e degli entri regolatori. Requisiti: Laurea in Biotecnologie/ CTF o similari Forte attitudine al problem solving e capacità di lavorare in team Buona capacità di analisi critica dei dati e dei processi Flessibilità e adattamento nei cambi di strategia di un progetto Buona conoscenza dell’inglese parlato e scritto Buona competenza di scrittura documenti Salary range: 35.000 - 38.000 Who We Are AGC 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. Across our global network, we are united by one mission: To work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.  AGC Biologics is Your Friendly CDMO Expert – dedicated partners with the expertise and commitment to support our customers and teams. We work with some of the world’s most innovative pharmaceutical companies to develop and manufacture their life-changing drug products. If you’re motivated by meaningful impact and ready to join our journey, we invite you to explore our current opportunities!

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19 Aug, 2026

Agcbio

Teamlead (f/m/d) - MSAT / Process Validation

Contract

Heidelberg Site, Germany

Contract

more at Agcbio.

Teamlead (f/m/d) - MSAT / Process Validation

Automatisierungsingenieur / -techniker (m/w/d) – Biotechnologie

Validation Scientist – Computer System Validation (CSV) (m/w/d)

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more at Agcbio.

Teamlead (f/m/d) - MSAT / Process Validation

Automatisierungsingenieur / -techniker (m/w/d) – Biotechnologie

Validation Scientist – Computer System Validation (CSV) (m/w/d)

similar roles.

Investor, Early Stage Team

Full Time Client Experience Coordinator / Chiropractic Assistant

Per Diem Virtual Pediatric Speech-Language Pathologist

Per Diem Virtual Pediatric Speech-Language Pathologist

Facilities Maintenance Specialist

CDL B Delivery Driver