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.

Join the premier life sciences park in the Netherlands. We’d love to have you on board!

Join us