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Method validation engineer

Job opportunity:  Method validation engineer

Eurofins Amatsigroup 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:
  • Drug substance biological process and analytical method development and production, including GMP manufacturing. The principal technological expertise is production and purification of recombinant proteins derived from microbial and eukaryotic systems, for research purposes and toxicological studies as well as for clinical trials, including formulation development and stress stability studies. The company also has extensive expertise in the manufacturing of viruses and living cells for vaccine purposes and in-depth knowledge of working under pharmaceutical and GMP quality requirements.
  • Drug product development of new drug candidates focusing on difficult to formulate drugs that are in preclinical, phase I or phase II clinical development. The company offers a full suite of drug development services encompassing preclinical development, preformulation development, formulation development, analytical development, dosage forms development, scaling-up and GMP manufacturing of chemical and biologicals drug candidates.
Eurofins Amatsigroup NV develops and produces non-sterile and sterile biologicals (drug substance and drug product) and chemicals (drug product) in preclinical and early clinical development phases. With approximately 400 staff worldwide, we operate out of 10 sites either in France and Belgium. To support our ambitious growth plan, we are today looking for a Method validation engineer for our site in Ghent, Belgium. Position: Method validation engineer Position/Responsibilities Eurofins Amatsigroup wishes to enforce its team with a Method validation engineer. We are looking for a person that reports to the QC Manager of Eurofins Amatsigroup NV. His/her main responsibilities are
  • Key responsibility: you are responsible for the validation of analytical methods to support the quality control testing of Drug Products used in clinical trials.
  • You interact with Analytical Development and Project management in preparation of validating the different analytical methods needed for the Drug Product Release and stability testing.
  • You write Validation Protocols in accordance with international recognized guidelines (ICH, FDA, Ph. Eur., USP).
  • You execute and follow-up the execution of the Validation Protocol in compliance with the GMP principles and the procedures of the Eurofins Quality Management System.
  • You calculate, review and summarize the analytical test results in Validation Reports
Education and experience
  • Master Degree with a scientific orientation (e.g. Analytical Chemistry or Pharmaceutical sciences) with a first profound professional experience, preferably in a pharmaceutical setting.
  • Key scientific knowledge: in-depth knowledge of Liquid Chromatography is a must (Waters U(H)PLC systems; UV/ELSD detectors and Empower CDS).
  • Proven record of accomplishment in analytical method validation.
  • Experience within a GMP environment is a major asset.
  • Experience with Karl Fischer, Dissolution, UV spectroscopy and Laser diffraction techniques provide added value.
  • Able to work independently after training in matters entrusted to you.
  • Team player with strong organizational and communication skills
  • Problem solving, flexible mindset whilst being punctual and quality driven.
  • Professionally fluent in English (written and spoken)
  • MS office adapted
We offer you
  • A position with responsibility within a dynamic company.
  • You will join a mix of young and experienced analysts and project leaders.
  • Personal development through learning on the job and additional external trainings
  • A market oriented compensation based on your relevant experience.
Interested in this challenging job? Please send your application including CV and motivation letter the career page of Eurofins, click here.
Thank you for applying for a career at Eurofins Amatsigroup
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Thank you for applying for a career at Amatsigroup
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