Equipment Qualification Engineer

  • Full-time

Company Description

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.

In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 50,000 staff across a network of more than 900 independent companies in over 50 countries and operating more than 800 laboratories. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing.  

In 2019, Eurofins generated total revenues of EUR € 4.56 billion, and has been among the best performing stocks in Europe over the past 20 years.

Eurofins CDMO is one of the leading CDMOs in Europe providing high-quality, customized drug development solutions for specialty and biopharma clients. Our focus is to support clients on the earliest phases of their development pathway (from API to the clinical packaging).
Its Belgian subsidiary, Eurofins Amatsigroup NV, is based in Ghent, offering a complete drug development package for new drug entities (biological and chemical) up to early clinical phases to third parties to help them in speeding up the development and manufacturing of their drugs.

Job Description

  • You are the end-responsible for the qualification and calibration of production, testing and monitoring equipment according to established procedures, applicable GMP guidelines and regulations.
  • You set up the qualification documentation including risk assessment, qualification plan and qualification protocols in consultation with the system owner and the Quality Assurance team.
  • You execute the qualification activities according the approved protocols
  • You supervise FAT & SAT testing and qualification activities according the approved protocols in case qualification is performed by a supplier
  • You are responsible for equipment lifecycle management including calibration, maintenance and re-qualification.

Qualifications

  • A minimum of a Scientific Master Degree (i.e. Industrial Engineering, Pharmaceutical Sciences, Bio-Engineering,) with three (3) years of experience in a GMP pharmaceutical production environment or equivalent by experience.
  • You have knowledge of Quality Management in a regulated environment (Eudralex-GMP, ICH).
  • You are flexible, quality minded and problem solving.
  • You are fluent in English (written and spoken).

Additional Information

  • Work in a fast growing organization.
  • A position with responsibility within a dynamic company.
  • Personal development through learning on the job and additional external trainings.
  • A market oriented compensation.
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