Process Engineer
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As a Process Engineer Support in the Sterile Manufacturing Department, you will support the Sterile Process Eng Team to implement departmental projects as technical user representative.
You will contribute by:
- 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:
- Definition of requirements (URS)
- Coordination all project activities to deliver on time
- Follow-up of development & implementation steps
- Testing for qualification/validation
- Drafting and/or reviewing protocols/reports, procedures and documentation
- 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 technologies
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