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.
- 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.