Process Engineer (medior level / 3-8 years experience)

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.

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;

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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