Ghent, Flemish Region, Belgium
Life science professional (manager process & team) in engineering & qualification with international experience and an analytical and process oriented mind. Working experience in: - Pharmaceutical technical area (clean utilities) - Aseptic manufacturing - Pharmaceutical and aseptic formulation - Medical device - API manufacturing - Filling and packaging - Plant construction - Cleanroom construction At: - Janssen Pharmaceutica fill finish - Janssen Pharmaceutica API - J&J innovative medicine - GSK Bio (Waver) - Innogenetics - Pfizer (Puurs) - MSD - NVI - Sterigenics (Petit-Rechain) - Laboratoria Smeets - Pannoc - Heel Belgium - Blispac
- Manager C&Q team - Owner C&Q processes (commissioning & qualification, equipment life cycle, VMP, periodic review...) - Spokesperson regulatory audits - Built C&Q team (internal & external) - C&Q resource allocation - Handover (receiving end) - Coach team members - Define C&Q strategy - Implement new processes - Budgetting
- Manager C&Q team - Owner C&Q processes - Built C&Q team (hire team members internal & external) - Develop C&Q processes - Manage resource allocation - Define improvements and implement - Externalization of specific C&Q processes (phased) - Coach team members - Define budgets
- Proces owner C&Q - Spokesperson regulatory audits - Member J&J global community of practice - Responsible contractors compliance work (+/-12) - Responsible contractors process improvements (+/-2)
Support global leadership in decissionmaking, vision and defining actions
Project management packaging equipment - Define - Design - URS - Construction - FAT - Installation - Support C&Q - Handover to end user Equipment standardization New technology & innovation - Feasibility study technology and implementation - Cross site/ industry benchmarks Packaging COE support to Xi'an Janssen site - T&T implementation (technology & process flow) - On site modifications - Packaging process validation
Projects: - PFIZER - STERIGENICS - PANNOC - HEEL Belgium - LABO SMEETS - JANSSEN PHARMACEUTICA General role - Engineering lead - Qualification & validation lead - Project management * Resource management * Scheduling * Implementation & execution * Contract & scope - Project strategy * Design approach * Implement strategy/approach * Consultancy - Qualification & validation * Implementation of C&Q approach (small manufacturers) * Strategy/ approach * Training
Tasks: - Strategy - Coordination - Restructuring, regrouping & reorganizing - Communication - Reposition of the organisation between the members and the corporate partners - Improve cooperation and ties to the engineering schools and university