We are currently recruiting for a Process Engineer (medior level / 3-8 years experience) to support projects on site at a client inthe region of Brussels.
Responsibilities
Your day to day role would involve the following activities:
As a Process Engineer Support in the Sterile Manufacturing Department, you will support the Sterile Process Engineering 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.
- Write and manage deviations, investigations & change controls, lead/Support technical investigations,
deviations and associated CAPA in the context of the projects. - 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;
Qualifications
We would like to hear from candidates who have:
- Theoretical and strong practical expertise in project management.
- Master’s degree as Bio-engineer, 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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