Operational Tech Transfer Specialist m/f/d
Job in
6106, Werthenstein, Kanton Luzern, Switzerland
Listed on 2026-03-05
Listing for:
Aristo Group
Full Time
position Listed on 2026-03-05
Job specializations:
-
Manufacturing / Production
Pharmaceutical Manufacturing, Validation Engineer, Manufacturing Engineer
Job Description & How to Apply Below
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
Project start: 02.03.2026
Tasks:
- Execute New Product Introduction (NPI) into GMP biologics manufacturing
- Convert development process data into GMP-ready documentation (BOMs, batch records, E /gBMR, sampling plans)
- Build and maintain digital manufacturing system data (MES, Delta
V, 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, Delta
V, SAP, and GMP documentation authoring - Experience managing small cross-functional projects
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