Validation Engineer at HALIX 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.
- 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.