Validation Engineer at HAL Allergy

HALIX delivers end-to-end bioscience services for therapeutic recombinant proteins, viral vectors and vaccines.

As a Validation Engineer you ensure availability of validated pharmaceutical systems (including production equipment) according to the EU / FDA directives.

Tasks and responsibilities

  • Ensuring routine validations of pharmaceutical systems including production equipment according to the EU / FDA directives.
  • Writes and implements cost effective validation methodology for changes in existing or new pharmaceutical systems. 
  • Insourcing or outsourcing of expertise and service.
  • Reporting of key process parameters and performance indicators including trending.
  • Ensuring good administration and archiving.  

Requirements

  • Academic bachelor with a technical training such as mechanical engineering with additional training and experience in life sciences (biotechnology or related).
  • A minimum of 5 years of recent experience in biotechnological pharmaceutical facilities.
  • Experience with biotechnological processes and CMC manufacturing.
  • Proven experience of outsourcing critical work to contractors.
  • Working knowledge of GMP/FDA guidelines.

Personal & Professional Skills

  • Customer focused and quality driven.
  • Proven strong project management skills.
  • Good communicator, team player.
  • Pro-active and solutions oriented.
  • Ability to work under time pressure.
  • Self-starter, hands-on, builder.
  • Good knowledge of English verbal and written.

Come and join us, find your next challenging job in our Job board. There is plenty of interesting and rewarding work in life sciences in Leiden.

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