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Validation Manager

  • Location

    Berlin

  • Sector:

    Quality, R&D

  • Salary:

    60,000EUR - 70,000EUR

  • Contact:

    Rebecca Stevens

  • Job ref:

    22323

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Validation Engineer

One of our clients, specializing in contract manufacturing of orthopedic devices/implants is currently looking for a Validation Engineer to take over responsibility for the processes and procedures in the area of end of line (cleaning, packaging, sterilization)

Your responsibilities:

  • Ensuring compliance with legal requirements, internal quality specifications and customer expectations (e.g CAPA management, change management, document control, training and quality risk management).

  • Independent planning, implementation and monitoring of qualifications/validations for medical technology production plants and processes.

  • Preparation/review of qualification and validation documentation, as well as master plans and reports.

  • Creation, processing and coordination of changes and deviations of validated processes.

Required Experience

  • Completed technical or scientific studies, preferably in medical technology, mechanical engineering, process engineering or biotechnology

  • At least 3 years of professional experience in the field of qualification and validation in a GMP regulated environment

  • Good knowledge of the application of the corresponding standards and regulations such as ISO 13485, FDA 21 CFR Part 820, DIN EN ISO 11137; DIN EN ISO 11607, ISO 19227 etc.

  • Very good knowledge of spoken and written English and German

  • Experienced handling of the corresponding Office programs

  • Strong ability to communicate and work in a team

Please apply with your CV or contact Kasia Krasuska for further details on this opportunity and additional vacancies in Regulatory Affairs and Quality Management.

Kasia.Krasuska@Adaptivelifescience.com

+49 30 16 63 83 76