Commercialization Packaging & Device Expert (NOVJP00024742) (m/f)

REFERENZNUMMER:

360334/11

IHRE AUFGABEN:

-Provide technical expertise from commercial point of view during device development stages and process commercialization
-Support Launch Site Decisions at e.g. PAC (Post Approval Commitment) by providing analysis of technology, capacity, skills by performing interfunctional evaluations
-Manage technical launch activities (process, technology, capacity, resources) for assembly and packaging at involved sites
-Assure that all activities are performed according to current processes and standards (GMP, HSE, Regualtory)
-Ensure PAI (Pre-Approval Inspection) readiness
-Act as a manufacturing representative during device development stages (design control)
-Act as a manufacturing representative in the packaging design process for the BTDM product portfolio

IHRE QUALIFIKATIONEN:

-Education (minimum/desirable): PhD, Dipl. Ing. in Mechanical Engineering or Pharmaceutical Technology
-Fluent in English and local language (German) an advantage
-Extensive experience in Pharmaceutical Manufacturing (preferably assembly & packaging) / Manufacturing Science and Technology / technical Development in assembly & secondary packaging projects
-Thorough understanding of product processes and strong working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities
-Knowledge in design control, documentation, risk management and processes such as DMR (Device Master Record), DHF (Design History File), pFMEA, Design Verification, and URS (User Requirement Specifications)

WEITERE QUALIFIKATIONEN:

Project manager