Manufacturing and QC Specialist

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!