Skip to main content

Validation Manager

Mol
  • Develop, realise and manage the qualification and validation system of our new facility for the production of therapeutic radionuclides
  • Support the full validation life cycle and contribute to the development of new pharmaceutical production processes
Apply now
Management & Operations

Will you come and help us in our fight against cancer?

With its new NURA programme, SCK CEN significantly increases its contribution to the fight against cancer.
NURA contributes to the development and supply of next-generation radiopharmaceuticals for treating different types of cancer, in cooperation with clinical and industrial partners.
A new facility for the GMP compliant production of Lu-177 radioactive precursor is currently under development.
We are looking for a Validation Manager to support the development, and in a later phase, the operation of this facility.
Your responsibilities include, but are not limited to:

  • Generate, maintain and co-approve Validation Master Plans (facility and utilities, processes, analytical methods, computer systems, cleaning, equipment) and strategies and guarantee execution
  • Provide technical expertise and ensure implementation and training of validation systems
  • Design and write validation project plans (manpower and resources, scheduling, and project planning)
  • Write, review, co-approve and execute validation Standard Operating Procedures (SOPs), protocols and reports for multiple validation disciplines
  • Participate in the selection of pharmaceutical equipment, by providing input to user requirement specifications
  • Contribute to pharmaceutical process development and the establishment of the control strategy in view of the validation life cycle
  • Support regulatory agency interactions.
  • Participate or assist in validation activities and supervises contractors

To join this frontier, you'll need

  • Master's degree in engineering, chemical technology, pharmaceutical technology or equivalent
  • Excellent communication and management skills to work in a multidisciplinary team in an international environment
  • Experience in design and developing a pharmaceutical production process and in project management is a considerable asset
  • Experience with nuclear applications, in particular radiochemistry or radiopharmacy, is an asset
  • At least 5 years of experience in a GMP environment; knowledge of GMP requirements related to validation
  • Proven experience with pharmaceutical processes, validation and regulation
  • Experience with data processing and applied statistics
  • Experience with risk assessment and related methods
  • Passionate with an entrepreneurial spirit
  • Willing to work in supervised and controlled areas where radiation protection measures apply

Deadline

Contact
Daan Caeyers
daan.caeyers [at] sckcen.be