At Univercells Tech, our mission is to make health equally accessible to all. We work every day to reinvent biomanufacturing processes and develop or integrate the next innovative technologies.
Through the combination of process development and engineering expertise, we create synergies to deliver game-changing production capacities to achieve our mission : Biologics available and affordable to all!! This job is the perfect opportunity to contribute to our mission and be impactful.
Based in Nivelles you will join a collaborative team full of passionate change-makers.Univercells is developing a new generation of biotech equipment (Scale-X and Nevoline) and in order to move forward with the development of our innovative products we are looking for a Process Engineer.
Your mission will be to translate requirements from the customer and their specific vaccine manufacturing process (URS) to requirements of the technical experts (FDS).
As a process owner, you will coordinate technical inputs from different experts of the development team, develop testing strategy and investigate in case of potential failure of the system (equipment and bioreactor).
Based on your experience of the vaccine manufacturing process, you will participate from the design to the validation of single-use manifolds and associated equipment.
You will manage PI&D, bill of materials, and develop manufacturing procedures. On a daily basis, you will carry out various engineering tasks, such as develop Design of experiment on new designs, risk analysis, define the quality of products through the entire production cycle to ensure our systems meet the global standards.
RESPONSIBILITIES Design new systems or part of systemWrite Functional Specifications based on URSDevelop Design of ExperimentWrite or review testing protocolExecute testing protocolAnalyze data on a statistical point of viewWrite or review reportParticipate to Design ReviewOwner of the investigation processQuality documentationRisk AssessmentDefinition of critical parameters and associated testsGather product requirements (e.
g. functionalities, speed, safety standards)Last but not least : Ensure good coordination with the manufacturing engineer’s, quality and logistic teamsQUALIFICATIONS & SKILLSBSC or Master degree SUS, mechanical or bioengineering2-5 years of experience in vaccine manufacturing or biopharmaceutical environmentKnowledge of SINGLE-USE SYSTEMS and equipment associated with vaccine manufacturing process knowledgeProven time management, organizational, and oral & written communication skillsFamiliar with Lean-SixSigma tools Green belt is a mustExcellent knowledge with root cause analysisFluent English (Dutch and / or French are an asset)