h3Process Engineer (m/f) - Fill Finish Process Innovation /h3h3Summary /h3pWe are seeking an experienced Process Engineer to join the Drug Product Development Delivery (DPDD) Process Innovation team. This role focuses on the development, optimization, and scale-up of fill finish processes for biologics, while driving innovation and supporting regulatory and technical development activities across multifunctional teams. /ph3Responsibilities /h3ulliLead process development and engineering activities for biologics fill finish operations. /liliAct as innovation lead for projects, identifying and implementing new technologies and process improvements. /liliDesign, execute, or oversee laboratory studies supporting process development initiatives. /liliDevelop and apply scale-down models to evaluate critical process parameters and support scale-up activities. /liliInvestigate and troubleshoot process performance issues using scientific and engineering principles. /liliSupport technology transfer activities from development to manufacturing. /liliPrepare and contribute to regulatory submissions, dossiers, and technical documentation related to fill finish processes. /liliCollaborate with development, manufacturing, and supply chain teams to analyze process data and drive continuous improvement. /li /ulh3Must-Haves /h3ulliBachelor's degree with 9+ years of experience or Master's degree with 6+ years of experience in a relevant scientific or engineering field. /liliStrong experience in process engineering within the pharmaceutical or biopharmaceutical industry. /liliProven experience supporting technology transfer and process scale-up activities. /liliKnowledge of biologics and sterile fill finish manufacturing processes. /liliExperience with freeze/thaw, mixing, filtration, and filling operations. /liliUnderstanding of Process Analytical Technology (PAT), including tools such as Raman spectroscopy, FlowVPX, or flow sensors. /liliExperience troubleshooting manufacturing and process performance issues. /liliExcellent communication skills in English and ability to work within cross-functional global teams. /li /ul #J-18808-Ljbffr
Process Engineer Arbeitgeber: BioTalent
Unser Kunde ist ein wachsendes Unternehmen im Bereich der Lebenswissenschaften, das seinen Mitarbeitern eine dynamische und unterstützende Arbeitsumgebung bietet. Hier haben Sie die Möglichkeit, aktiv zur kontinuierlichen Verbesserung des Qualitätsmanagementsystems beizutragen und Ihre Fähigkeiten in einem regulierten Umfeld weiterzuentwickeln. Die Unternehmenskultur fördert Teamarbeit und persönliche Entwicklung, während attraktive Schulungs- und Weiterbildungsmöglichkeiten sowie ein klarer Fokus auf Qualität und Compliance Ihnen helfen, Ihre Karriere voranzutreiben.
