Company

Qualification & Validation Specialist (m/f/d)

Heilbronn, Germany, Europe

Company Overview:

ProtaGene is a world-leading analytic CRO partner for the biopharmaceutical and cell and gene therapy industries. From research through product commercialization, we provide the most advanced, integrated, and Quality system driven analytic capabilities and packages for biologic therapeutics as well as cell and gene therapy platforms. Our deep history of analytical leadership in protein-based therapeutics stems from the merger of Protagen Protein Services in Europe and BioAnalytix in the US. In 2021 GeneWerk’s unique capabilities in vector safety, integration site analysis, and bioinformatics were integrated into our platforms and service offerings, establishing ProtaGene. The organization operates over four sites in Europe and North America, and works with leading large pharma, biopharmaceutical, and gene therapy companies worldwide.

Please click here to see the German Translation.

Responsibilities:

  • Interdisciplinary work between the laboratory, IT and quality assurance
  • Conduction of risk analyses (e.g. FMEA) relating to devices, premises and software
  • Filing and review of qualification and validation documents for analytical devices and premises as well as software
  • Execution of qualification and validation tests
  • Filing and revision of SOPs
  • Conducting training courses
  • Coordination and monitoring of periodic reviews and requalifications / revalidations
  • Monitoring of maintenance for devices
  • Support with sponsor and governmental audits

Qualifications:

  • Successfully completed studies in natural sciences (Biology, Chemistry or equivalent).
  • Good GxP knowledge and knowledge of regulatory requirements.
  • Ideally several years of industrial work experience in the fields of coordination and implementation of qualification/validation activities.
  • Several years of experience in project planning and management as well as in staff management.
  • Good command of the English language, both written and spoken.
  • You work in a solution-oriented manner and enjoy active communication with colleagues.
  • Diligence, reliability and organizational skills complete your profile.

We offer:

  • Responsible and varied tasks in a motivating working environment
  • A permanent position in a dynamically growing life science group of companies with over 170 employees
  • Optimal training and individual development opportunities
  • Fresh fruit and drinks at your free disposal
  • Appreciation, openness and respect as well as a lively feedback cultur

We are looking forward to receiving your complete application documents in English or in German, including a letter of motivation, information on the possible starting date and your salary expectations in one or two PDF files by e-mail to: careers-eu@protagene.com

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