Jürgen Scholz

• Team Lead Drug Products / Fill & Finish within the Biopharma & Life Sciences business unit • SME for the topics Aseptic & Containment; Isolator-, Filling- & Sec. packaging-equipment • Planning the F&F-part for customer project studies from feasibility up to the detail-phase • Generate equipment specific user requirements & tender packages • Technical bid evaluation • Cost estimation and scheduling • cGMP optimized layout planning

- Manage customer projects from the final order intake until the service handover; including all technical and commercial topics alongside the project-roadmap. - Monitor and control scheduled milestones and target-costs as well as tracking change- and claim-management.

- Process design for aseptic and ultra-clean packaging machines - Worldwide commissioning of process equipment (FAT, SAT); including supervision of microbiological challenge and approval test series (US, Asia, EU) - Design PIDs and layout-constructions for CIP- and SIP-process modules; define process step-chains; - Generate risk assessments, user manuals, SOPs and filing documents - Contact person and coordinator for FDA-projects and 3-A-sanitary standard certificate