Job description Company Description Do 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 Description This 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.
Qualifications Manufacturing operations in cleanroom environments (ISO 8) – being hands-on! Equipment qualification and requalification (IQ/OQ/PQ) Process validation and cleaning validation Calibration and maintenance programs Raw material handling, traceability, and inventory management Execution of QC testing with analytical equipment and batch release testing Implementation of sampling plans Operational implementation of packaging and sterilization activities Execution of stability studies (pulls, testing, trending) ERP, logistic and packaging/labelling knowledges Experience in organic chemistry Analytical skills for analyzing test results and interpreting data Strong 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)
Profile Hands-on! You are willing to work in the production, besides the QC part. Practical experience in synthetic organic chemistry Experience in characterization methods, analytical chemistry and processing techniques Knowledge of biopolymers and hydrogels Good knowledge of the English language, spoken and written Proven experience in the medical device industry Solid understanding of ISO 13485 and EU MDR 2017/745 Ability to think and act in a medical device regulatory mindset Comfortable working in small teams with high autonomy and responsibility Strong 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 package Meal vouchers Hospitalisation Insurance State-of-the art working tools Contributing to groundbreaking medical technology Working with a great team Expand your knowledge through internal training Personal 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!