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Manufacturing and QC Specialist
Manufacturing and QC SpecialistAllegro Biotech • Luik, Luik (gemeente); Luik (arrondissement); Provincie Luik; Waals Gewest, Belgium
Manufacturing and QC Specialist

Manufacturing and QC Specialist

Allegro Biotech • Luik, Luik (gemeente); Luik (arrondissement); Provincie Luik; Waals Gewest, Belgium
Il y a 4 jours
Description de poste

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!

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    Manufacturing and QC Specialist • Luik, Luik (gemeente); Luik (arrondissement); Provincie Luik; Waals Gewest, Belgium

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