As a Senior Process Engineer - Sterilization, you will be part of the Manufacturing Science and Technology (MSAT) team, responsible for developing and executing sterilization and decontamination cycles (autoclaves and VHP) and ensuring their validation and implementation. You will lead technical investigations, drive process improvements, and collaborate closely with cross-functional teams to enhance manufacturing efficiency and compliance.
Ensure seamless knowledge transfer across functions within MSAT and other relevant teams.
Perform data trend analysis and evaluate process performance, including validation study assessments.
Minimum of a Master’s degree in Engineering, Science, Pharmacy, or a related field. 5 years of relevant experience in a cGMP environment within the pharmaceutical industry.
~+Strong background in sterilization/decontamination validation and manufacturing support.
Languages:
~ Fluent in English (knowledge of Dutch is a plus).
Team-oriented mindset with the ability to build strong cross-functional partnerships.
Experience in conducting root cause analysis and implementing corrective and preventive actions.
Strong statistical analysis skills for data-driven decision-making.
Familiarity with regulatory submission processes and requirements for manufacturing validation.