Pauwels Consulting
Pauwels Consulting, with head offices in Diegem and Ghent, is a fast-growing, independant and dynamic company with more than 100 employees. For over ten years Pauwels Consulting has been a loyal partner with expertise in IT, Engineering and Pharma for plenty of clients in Belgium, the Netherlands, Germany and France. In IT we offer global solutions with new technologies for application and web development, Business Intelligence and data warehouse. Our network and system engineers support our clients with our infrastructure services, helpdesk and support in different operating systems. In Engineering Pauwels Consulting is the number one partner for large (petro)chemical, industrial and production companies in Belgium and the Netherlands. We offer solutions for design, process, construction and supervision of specific projects. The consultants in our business unit Engineering Services can always be hired for solid support to industrial projects. Pauwels Consulting is also the perfect Pharma partner, not just for pharmaceutical and biotech companies, but also for their suppliers. Our consultants validate computer systems, processes, lab equipment and other specific applications. Our experts also provide on site quality control, audits and analysis, and GMP training and coaching and even product support. If so desired, we can set up projects from a to z (Special Projects). Pauwels Consulting’s strength lies in our consultants. Pauwels’ consultants are flexible and enthusiastic high potentials, and we are very happy to put our experience and expertise to work for the success of our clients.
Process Robustness Validation Engineer
Functieomschrijving
Participate in the Process Validation (PV) and Process Robustness activities mainly on secondary manufacturing processes (i.e. immunostimulants, adsorption, formulation, filling and freeze-drying), for both under-development and commercialized vaccines.
• Analysis of vaccine manufacturing processes and identification of critical and non-critical parameters of the manufacturing process modules
• Establish evaluation plans and analyse results
• Analysis of the Process Consistency of the manufacturing processes, support in the completion of the Process Consistency protocols and reports
• Establish Process Validation documents
• Support to Request for New File (RNF) and Request for Process Change (RPC) related to the processes
• Assure the coherence and harmonization between the Process Validation data created and submitted in the Regulatory files, as well as between the different projects
Profiel
• University degree (biochemical engineer, agronomy engineer, chemical engineer, biotechnology, …)
• Expertise in Secondary operations (formulation, Filling and freeze-drying)
• 2 to 5 years of experience in pharmaceutical validations
• Excellent written and spoken, both French and English
• Capability of working transversally with different departments
• Capability of managing several different projects at the time
• Good communication skills
• Sense of urgency
Aanbod
- A position with responsability within a leading international company
- Personal development through learning on the job and additional external trainings
- A market oriented compensation, including a range of fringe benefits