What can you expect? 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.
Your Responsibilities
* Develop and execute sterilization and decontamination cycle validation strategies in alignment with product requirements.
* Lead/support the design of business cases, study designs, and project implementations.
* Act as a Subject Matter Expert (SME) for sterilization and decontamination processes.
* Ensure seamless knowledge transfer across functions within MSAT and other relevant teams.
* Perform data trend analysis and evaluate process performance, including validation study assessments.
* Provide scientific and cGMP expertise to support process lifecycle activities and ensure compliance with regulatory requirements.
* Lead and support large-scale projects focused on process optimization and operational excellence.
* Participate in regulatory inspections and contribute to compliance-related documentation such as Change Controls, CAPAs, and risk assessments.
Who are we looking for?
Education:
* Minimum of a Master’s degree in Engineering, Science, Pharmacy, or a related field. An advanced degree is preferred.
Experience:
* 5-10 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).
Strengths:
* Ability to work independently with minimal guidance.
* Strong organizational skills, capable of managing multiple priorities in a fast-paced environment.
* Excellent communication and presentation skills.
* Ability to synthesize complex technical issues and communicate effectively at all organizational levels.
* Strong problem-solving, analytical, and critical-thinking skills.
* Team-oriented mindset with the ability to build strong cross-functional partnerships.
* A results-driven approach with a commitment to continuous improvement.
Expertise:
* In-depth knowledge of cGMP regulations related to sterilization and decontamination processes.
* 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.