As a Sterilisation Validation Analyst you will be responsible for the drafting test protocols and reports, and defining the sterilization approach for projects in accordance with cGMP, and legal standards, particularly for changes to existing equipment or new devices.
* Planning, coordinating, and monitoring the practical implementation of tests.- Conducting research for deviating or non-compliant results
* Updating necessary GMP documentation after study completion
* Coordinating project activities within team
* Communicating with the project team regarding planning, status, problems, and report deadlines
* Ensuring appropriate training and development for the team to facilitate a smooth transfer to the routine program
* Participating in site and corporate teams and audits related to their expert domains
* Working on efficiency, optimization, and innovative projects to drive continuous improvement
* Practical implementation of planned validation tests for their own and colleagues' projects, covering both revalidations and requalifications
Qualifications:
* Bachelor's degree in Industrial, Civil, or Bio-engineering, or Industrial Pharmacy, or demonstrate equivalent experience
* Strong social and organizational skills, with the ability to work effectively as a team player
* Proficiency in PC software applications is necessary, along with a perfect command of both Dutch and English, and a good technical writing style
* Strong problem-solving ability, including creativity to address deviations and suggest improvements
* Strong interpersonal skills and the capacity to work in an organized and accurate manner, with a genuine interest in technology (e.g., measurement equipment, software)
* Willing to work in a two-shift system (6am-2pm and 2pm-10pm)
* Prior experience in similar projects and within a GMP environment is considered an advantage