Job descriptionCompany DescriptionDo you dare to shake up the medical world and improve the lives of patients with chronic degenerative diseases?Allegro is a revolutionary start-up that designs and develops ground-breaking biomedical nanotechnology for the treatment of osteoarthritis.
Role DescriptionThis is a full-time role for a Manufacturing and QC Specialist at Allegro Biotech in Liège. As a Manufacturing and QC Specialist, you will be responsible for production runs and upscaling (lab to pilot), performing analytical tests, maintaining laboratory equipment, perform quality control. This is an on-site role where you will work in our laboratory facilities in Liège.
QualificationsManufacturing operations in cleanroom environments (ISO 8) – being hands-on!Equipment qualification and requalification (IQ/OQ/PQ)Process validation and cleaning validationCalibration and maintenance programsRaw material handling, traceability, and inventory managementExecution of QC testing with analytical equipment and batch release testingImplementation of sampling plansOperational implementation of packaging and sterilization activitiesExecution of stability studies (pulls, testing, trending)ERP, logistic and packaging/labelling knowledgesExperience in organic chemistryAnalytical skills for analyzing test results and interpreting dataStrong attention to detail and accuracy in documentation
Key regulatory and standards knowledge expected:EU MDR 2017/745 (operational application)ISO 13485 (manufacturing, documentation, batch records, GDP)ISO 14644 (cleanrooms)ISO 11737 (bioburden, endotoxins, sterility testing interface)ISO 11607 (packaging validation and routine controls)ASTM F3127 (cleaning validation)ASTM F88 / F1886 / F1929 / F2096 (packaging integrity & seal testing)
ProfileHands-on! You are willing to work in the production, besides the QC part.Practical experience in synthetic organic chemistryExperience in characterization methods, analytical chemistry and processing techniquesKnowledge of biopolymers and hydrogelsGood knowledge of the English language, spoken and writtenProven experience in the medical device industrySolid understanding of ISO 13485 and EU MDR 2017/745Ability to think and act in a medical device regulatory mindsetComfortable working in small teams with high autonomy and responsibilityStrong project management skills combined with a hands-on mindset
We offer
We offer great career opportunities for ambitious people within a thriving environment. We offer a very competitive remuneration package and various fringe benefits:
Competitive salary packageMeal vouchersHospitalisation InsuranceState-of-the art working toolsContributing to groundbreaking medical technologyWorking with a great teamExpand your knowledge through internal trainingPersonal and professional development process
Please apply through LinkedIn or send your CV+cover letter to hr@allegro.bio. We look forward to meeting you soon!