Process Engineer
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• Supporting projects in the sterile manufacturing plant required to deliver the department strategy and roadmap, in full scope and on time
• Providing technical support to the sterile manufacturing team for troubleshooting, equipment investigation, digitized processes, etc.
• Drafting, reviewing and/or approving cGMP documents relating to operations, in compliance with procedures and cGMP guidelines, within the framework of projects
• Being the point of contact, trainer and coach for the various end users in implementing projects (digital and/or engineering)
• Provide technical support to the production for troubleshooting, investigation, etc.
• Act in accordance with GMP compliance in all activities, ensure compliance of all business-related activities
• Maintain all activities in “Permanent Inspection Readiness” mode, contribute to achieving the Sterile Manufacturing department's compliance objectives and indicators
• Manage digital and non digital projects and/or be the department's point of contact for the implementation of projects: o Definition of requirements (URS) o Coordination all project activities to deliver on time o Follow-up of development & implementation steps, o Testing for qualification/validation o Drafting and/or reviewing protocols/reports, procedures and documentation o Team training, coaching and field follow-up for the first batches
• Write and manage deviations, investigations & change controls, lead/Support technical investigations, deviations and associated CAPA in the context of the projects Profile
• Theoretical and strong practical expertise in project management
• Master’s degree as Bioengineer, Process Engineer, Mechanical Engineer, Chemical Engineer, Industrial Pharmacist, Chemist, Biologist, or proven experience
• Strongly safety minded and knowledgeable of industry safety standards
• Good knowledge of GMP requirements for sterile product development & manufacturing
• Strong knowledge in aseptic manufacturing practices, bulk filling, aseptic filling
• Knowledge in visual inspection processes: manual, semi-automatic, as fully automatic is a plus
• Good knowledge of project management methodology
• Very good interpersonal communication skills to foster collaboration with internal customer and support departments
• Autonomous and rigorous, with an out-of-the-box approach for problem solving and an excellent team working mindset
• Ability to work in a highly matrixed and dynamic environment
• Ability to prioritize and organize daily tasks to meet deadlines, remain focused and be proactive (multitasking)
• Knowledgeable of innovative and practical solving problems technologies
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