Founded in 2012 as a corporate venture and spin-off of HAL Allergy, HALIX is a contract development and manufacturing organization (CDMO), based in Leiden, the Netherlands. The company is licensed for the contract manufacturing of clinical and commercial medicines according to GMP standards. HALIX leverages advanced biopharmaceutical technologies and provides the full portfolio of pharmaceutical documentation of GMP production processes, as well as production of units which are required for clinical approval. HALIX, as an end-to-end service provider, will serve its customers the full range from the first development steps to start of commercial production after successful registration of products.
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 & 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.
- We offer you a highly dynamic job in an interesting environment
- You will be working from our headquarters in Leiden, where the products are produced on site.
- HALIX offers great benefits including a competitive salary and contribution to pension and health insurance.
Applications and more information
Interested? We look forward to receiving your application (before 31/03/2019). To apply, please click this link.
For more information, please contact the HR department at firstname.lastname@example.org.
We look forward to be receiving your application.
Keywords: Vacancy, Research, Mechanical engineering, Life sciences, Biotechnology, Biotechnological pharmaceutical facilities, Laboratoriumonderzoek, Leiden, Zuid-Holland