Facility Manager at HAL Allergy

HALIX delivers end-to-end bioscience services for therapeutic recombinant proteins, viral vectors and vaccines. The facility manager ensures the facility GMP status according to EU/FDA directives at all times. The facility manager ensures safe and good working conditions throughout the facility and property. 

Tasks and responsibilities

  • Establish and execute business continuity planning.
  • The performance of direct reports measured against the mile stone deliverables.
  • Maintain and upgrade permits which are required for the activities of HALIX: the environmental permit (omgevingsvergunning), the application and permits for working with genetic modified organisms (beschikkingen van bureau GGO).
  • Communication with and inspections from authorities: the municipal of Leiden, the regional body for environment (omgevingsdienst) and the body responsible for genetic modified organisms (bureau GGO). 
  • Ensuring company policy compliant to the current legislation and guidelines for safety, health and environment (SHE).
  • Ensuring cost effective use of energy and applying energy saving methods.
  • Treatment and disposal of all types of waste incl. waste water and genetically modified waste.
  • Ensuring adequate pharmaceutical cleaning and disinfection regimes are applied throughout the facility.
  • Implementing a change or adding new pharmaceutical systems including technical design and validation methodology.
  • Ensuring maintained and validated status of pharmaceutical systems including production equipment.
  • Ensuring at all times for planned availability of maintained and validated pharmaceutical systems including production equipment according to the EU / FDA directives.
  • Ensuring operational systems that are required to comply with the production plan at all times.
  • Maintain the design and quality of the exterior and interior of the facility and yard.
  • Outsourcing of critical work to contractors.

Requirements

  • Academic bachelor with a technical training such as mechanical engineering with additional training and experience in life sciences (biotechnology or related).
  • 7+ years of experience in biotechnological pharmaceutical facilities.
  • Experience with biotechnological processes and CMC manufacturing.
  • Knowledge of maintenance and validation requirements of pharmaceutical systems.
  • Knowledge of legislation and guidelines for safety, health and environment (SHE)
  • Working knowledge of GMP/FDA guidelines.

Personal and professional skills

  • Customer focused, quality driven with a continuous improvement mind set.
  • Proven strong scientific, project & people management skills.
  • Strong communicator and ability to build bridges between groups and organizations.
  • Able to carry out several activities and projects in parallel.
  • Pro-active and solutions oriented.
  • Ability to work under time pressure.
  • Self-starter, hands-on, builder.
  • Good knowledge of English, both verbal and written. Dutch advantageous.

Find out more about drug development at Leiden Bio Science Park.

R&D