VIQI is a consulting company specialized in the healthcare and life sciences industry, supporting pharmaceutical and biotechnology companies in their engineering, quality and manufacturing projects.
To support one of our clients based in the Liège area, we are currently looking for a Senior Process Engineer with strong expertise in aseptic fill & finish operations.
Your responsibilities
As Senior Process Engineer, you will play a key role in the design, transfer and optimization of sterile manufacturing processes.
Your responsibilities will include:
* Leading the design and continuous improvement of fill & finish processes (formulation, filtration, aseptic filling, visual inspection)
* Managing technical transfer and New Product Introduction (NPI) activities for new customer projects
* Developing validation and transfer strategies and coordinating process validation activities
* Supporting clinical batch manufacturing from a process engineering perspective
* Authoring and reviewing GMP process documentation (URS, validation protocols and reports, Master Batch Records, work instructions)
* Leading Quality Risk Management activities and contributing to contamination control strategies
* Performing process investigations and data analysis using statistical tools such as Minitab
* Acting as a technical interface with customers throughout project execution
Your profile
* Master’s degree or Engineering degree in Bio-engineering, Chemical Engineering, Industrial Pharmacy or Biotechnology
* Minimum 10 years of experience in the pharmaceutical industry, including at least 5 years in Process Engineering
* Strong expertise in aseptic processing and sterile fill & finish operations
* Proven experience in process validation, technical transfer and process optimization
* Good knowledge of Quality Risk Management methodologies (pFMEA, HACCP or equivalent)
* Experience with statistical process analysis tools
* Solid understanding of EU GMP Annex 1 requirements
* Customer-oriented mindset and excellent communication skills
* Experience in biotechnology or cytotoxic products is considered an asset
* Familiarity with ERP, MES or eQMS systems is a plus
Position available ASAP.
Salary starting from €45K gross annually.
Join us for an exciting and rewarding collaboration!