Uniqure zoekt een

Validation Engineer III

Amsterdam, Netherlands

Validation Engineer III

uniQure is dedicated to bringing innovative therapies for unmet medical needs to patients. In doing so each function in uniQure is directly or indirectly responsible for the lives of patients. This responsibility should be part of our day-to-day working life by (i) living up to high quality standards and (ii) by recognizing the sense of urgency in areas of high medical need.

The Role

The incumbent is responsible for assisting the Validation area lead in completion of all project milestones as well as manufacturing support. This includes performance qualification of equipment and utilities, environmental qualification, process transfer and scale-up, process validation, preparation of cGMP materials and preparation of all relevant documentation to meet regulatory requirements for new and existing products (includes standard operating procedures, technical reports and risk assessments).

Key Responsibilities:

The candidate’s responsibilities will include, but are not limited to:

  • Protocol generation, execution support, data analysis, report generation and approval for various installation, operational and performance qualification activities
  • Review and approve qualification documentation on behalf of the validation department.
  • Ensure performance of all qualification activities is in accordance with local procedures, industry and regulatory guidance.
  • Support investigations into protocol nonconformances and site deviations.
  • Serve as initiator and owner of validation related change controls and corrective and preventative actions.
  • Author standard operating procedures related to validation practices.
  • Support the execution and generation of formal risk assessments.
  • Support the generation and implementation of validation programs.

Blijf op de hoogte van vacatures zoals deze

of

Blijf op de hoogte van de laatste vacatures