Process Engineer (m/f) - Fill & Finish Process Innovation
Summary
We are seeking an experienced Process Engineer to join the Drug Product Development & Delivery (DPD&D) 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.
Responsibilities
- Lead process development and engineering activities for biologics fill & finish operations.
- Act as innovation lead for projects, identifying and implementing new technologies and process improvements.
- Design, execute, or oversee laboratory studies supporting process development initiatives.
- Develop and apply scale-down models to evaluate critical process parameters and support scale-up activities.
- Investigate and troubleshoot process performance issues using scientific and engineering principles.
- Support technology transfer activities from development to manufacturing.
- Prepare and contribute to regulatory submissions, dossiers, and technical documentation related to fill & finish processes.
- Collaborate with development, manufacturing, and supply chain teams to analyze process data and drive continuous improvement.
Must-Haves
- Bachelor's degree with 9+ years of experience or Master's degree with 6+ years of experience in a relevant scientific or engineering field.
- Strong experience in process engineering within the pharmaceutical or biopharmaceutical industry.
- Proven experience supporting technology transfer and process scale-up activities.
- Knowledge of biologics and sterile fill & finish manufacturing processes.
- Experience with freeze/thaw, mixing, filtration, and filling operations.
- Understanding of Process Analytical Technology (PAT), including tools such as Raman spectroscopy, FlowVPX, or flow sensors.
- Experience troubleshooting manufacturing and process performance issues.
- Excellent communication skills in English and ability to work within cross-functional global teams.
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Process Engineer in Schaffhausen 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.
