Process Engineer (Aseptic & DNA free)

miDiagnostics is working on the development and commercialization of an ultra-rapid CAR-T sterility test for the CAR-T manufacturing platform. As the Process Engineer (Aseptic & DNA free), you will play a pivotal role in developing, and implementing the highest standards of sterility and DNA controls in all aspects of the company operations including laboratories and cleanroom facilities. Initially, you will be supporting R&D efforts to develop and implement relevant processes. As the project advances, you will lead the transition to scalable sterile & DNA-free operations mainly through contract manufacturing partners.

Key Responsibilities

General:

• Serve as the subject matter expert on microbiology and nucleic acid-free processes, ensuring highest standards of sterility and DNA contaminations controls are implemented and well-integrated in daily laboratory operations from the early stage development of products all the way through manufacturing.

Process Development:

• Partner closely with the R&D team to design, develop and implement sterilization and nucleic acid-free decontamination methods (eg. for cartridges and reagents).
• Provide technical guidance on the impact of sterilization and nucleic acid-free methods on materials and final product performance.
• Advise on material & supplier selection in collaboration with the R&D team, ensuring compatibility with sterilization and nucleic acid-free requirements.
  
• Support the evaluation, and troubleshooting of sterilization and nucleic acid-free processes during the product development phases.

Manufacturing and Quality:

• Collaborate with internal & external partners to develop an end-to-end supply chain capable of delivering a sterile & nucleic acid-free product (e.g., Sterility test).
• Ensure that sterilization and nucleic acid-free methods are reproducible and scalable for scale-up manufacturing.
• Support the implementation of quality control (QC) procedures for sterilization and nucleic acid-free decontamination during both R&D and production phases.
• Conduct quality assessments of suppliers' sterilization and nucleic acid-free processes and work with Supplier Quality to ensure raw materials meet required standards.
• Assist with creation and revision of technical documentation (e.g., changes controls, SOPs, and batch records) as well as support deviation investigations and corrective and preventive actions (CAPA) as a technical resource.

Monitoring and Process Improvement:

• Develop and implement environmental bioburden and DNA contamination monitoring systems during early-stage production.
• Track data, analyze trends, ensure all Sterile & DNA-Free operations are conducted to the highest quality standards and make data-driven decisions for process improvements (Internal & External).

As our Process Engineer (Aseptic & DNA free), you are reporting to the VP Manufacturing and Supply Chain.

• Master’s degree in Microbiology, , Molecular Biology or equivalent
• 10+ years of hands-on experience in sterile and nucleic acid-free production, with a preference for experience in early-stage product development within the biopharma or life sciences sector
• Demonstrated expertise in sterilization processes (e.g.,hardware and reagent), DNA-removal techniques, and environmental monitoring
• Experience in working within an early-stage product development
• Experience with GMP (Good Manufacturing Practice) and regulatory requirements for sterilization and biopharma manufacturing
• Experience in scaling operations from R&D to commercial manufacturing through contract manufacturing organizations
• Strong problem-solving skills, particularly in developing and troubleshooting sterilization and nucleic acid-free processes
• Experience working with external manufacturing partners and scaling production processes
• Proficiency in quality control and supplier quality assessments for sterile and nucleic acid-free environments
• Data analysis skills and the ability to set up performance monitoring systems
• You feel comfortable in a start-up environment and you can easily switch from one task to another
• You appreciate working in an open space amongst enthusiastic, multidisciplinary and international colleagues
• You are fluent in English
  
• You're entitled to live and work in Belgium. We expect you to be on site, in Leuven, at least 60 to 70% of your time