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GMP Technical Specialist

80%-100%, Basel, permanent

The ETH GMP Platform (EGP) will support and enable academic research investigators (ETH Zurich, University of Basel) to manufacture investigational medicinal products, mainly ATMPs (cell, tissue and gene therapy), in compliance with GMP national and international guidelines for early clinical studies. The GMP facility, including clean rooms and QC laboratories, will be operational in 2022, in the new ETH-DBSSE building in Basel (Schällemätelli Campus).

Job description

As member of the core team, the GMP Technical Specialist supports the platform and its users in all aspects related to technical infrastructure, equipment, instrumentation, documentation and process implementation. Position requirements include but are not limited to

Tasks and Responsibilities

  • Ensure and maintain, in coordination with the EGP core team, the GMP compliance and functional status of the EGP premises and equipment
  • Support the facility users using EGP equipment and instruments (e.g. bioreactors, air samplers)
  • Support Quality Control manager with the EGP environment and media monitoring and the QC procedures for materials and suppliers
  • Actively participate in the EGP facility planning, procurement, qualification/requalification processes

Documentation and Inspections

  • Support the QA and QC managers to maintain the EGP Quality Management System
  • Write or review GMP documents
  • Participate in inspections by regulatory authorities

Training activities

  • Train and/or supervise for EGP procedures (e.g. entry and gowning), maintenance staff, service providers and users using the EGP premises and equipment
  • Participate in the theoritical training of facility users in GMP and QC concepts
  • Support users during the development of their projects (validation-qualification steps, SOPs, manufacturing protocols)
  • Follow new training-courses (e.g. new instruments, new procedures, GMP continuous education)

Your profile

Required

  • A degree equivalent to at least a technician degree (German equivalent) or a Bachelor in biology or chemistry, or chemical engineering or a dedicated diploma (e.g CAS) in pharma-manufacturing-quality system
  • Previous training and experience in GMP environment (minimum 2-3 years)
  • Level of English and German (written-spoken) enabling adequate communication with international academic personnel as well as regional service teams

Appreciated

  • Experience with microbiology, cell/gene therapy technologies and equipment management (e.g. bioreactors)
  • Experience with electronic management system (eDMS-eQMS...)
  • Excellent communication skills

ETH Zurich

ETH Zurich is one of the world’s leading universities specialising in science and technology. We are renowned for our excellent education, cutting-edge fundamental research and direct transfer of new knowledge into society. Over 30,000 people from more than 120 countries find our university to be a place that promotes independent thinking and an environment that inspires excellence. Located in the heart of Europe, yet forging connections all over the world, we work together to develop solutions for the global challenges of today and tomorrow.
Working, teaching and research at ETH Zurich Link icon

Interested?

We look forward to receiving your online application with the following documents (in English):

  • CV 
  • motivation letter (max 1page)
  • ev. support letters
  • diplomas/University degree(s)

Questions regarding the position should be directed to Dr. Paul ZAJAC by e-mail: paul.zajac@bsse.ethz.ch (no applications).

For recruitment services the GTC of ETH Zurich apply.

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