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Operational Tech Transfer Specialist (m/f/d) (EN)
[17165]
MES, DeltaV, NPI
Hands-on Tech Transfer/NPI specialist embedded in GMP operations, responsible for translating early-phase biologics (mAb) processes into executable GMP manufacturing documentation and digital systems. This role focuses on process implementation, digital alignment, and supporting a multi-product clinical biologics facility. Project title: Operational Tech Transfer Specialist (m/f/d) Type of employment: Payroll Industry: Engineering Skills: MES,DeltaV,NPI Project start: 02.03.2026 Project duration: 12 months Location: Schachen, 6105 Werthenstein, Switzerland Tasks: ·Execute New Product Introduction (NPI) into GMP biologics manufacturing ·Convert development process data into GMP-ready documentation (BOMs, batch records, EBR/gBMR, sampling plans) ·Build and maintain digital manufacturing system data (MES, DeltaV, SAP COMET) ·Perform risk assessments, change controls, and facility fit evaluations ·Coordinate cross-functional tech transfer activities and timelines ·Support digitalization and continuous improvement of tech transfer processes Qualifications: ·5+ years in GMP biologics drug substance manufacturing ·Strong understanding of mAb upstream and downstream operations ·Proven experience in Tech Transfer/NPI execution ·Hands-on experience with MES, DeltaV, SAP, and GMP documentation authoring ·Experience managing small cross-functional projects
- Execute New Product Introduction (NPI) into GMP biologics manufacturing
- Convert development process data into GMP-ready documentation (BOMs, batch records, EBR/gBMR, sampling plans)
- Build and maintain digital manufacturing system data (MES, DeltaV, SAP COMET)
- Perform risk assessments, change controls, and facility fit evaluations
- Coordinate cross-functional tech transfer activities and timelines
- Support digitalization and continuous improvement of tech transfer processes
- 5+ years in GMP biologics drug substance manufacturing
- Strong understanding of mAb upstream and downstream operations
- Proven experience in Tech Transfer/NPI execution
- Hands-on experience with MES, DeltaV, SAP, and GMP documentation authoring
- Experience managing small cross-functional projects
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