We are currently looking for a Sterilization Engineer for one of our clients in the regio of Leuven.
Development, implementation, supervision and coordination of all monitoring and process/product (re)qualification activities (IQ/OQ/PQ) related to (changes of) sterilization to assure product sterility in accordance with the applicable standards. Daily monitoring of the sterilization process of products manufactured.
Job Responsibilities
* Develop sterilization cycles for new product introductions and take ownership of the introduction in the plant - from equipment selection to executing qualification activities in-house or in collaboration with a sub-contractor. Once implemented, guard compliance and efficiency of the process. All these activities to be executed in close collaboration with Product Engineering to ensure all product requirements are met
* Organize, perform and coordinate (re)validation activities of the sterilizers (both in- and at the sub-contractor) as well as any other critical equipment in line with company procedures and international standards
* Daily monitor the sterilization process (both in- and at the sub-contractor) (incl. review of sterilization results and release) and coordinate the implementation of countermeasures and actions in case of deviating process results
* Monitor the need for upgrading sterilization cycles in accordance with increasing market demand (e.g. development of new products) and keeping cycle efficiency (throughput) high at lowest cost
* Monitor and evaluate regulatory standards for changes to ensure that the sterilization processes implemented in Europe remain compliant with the applicable standards and are translated as such in internal procedures
* Evaluate potential sterilization impact and define required actions in case of changes (e.g. new product introductions, design and packaging configuration changes, modifications to sterilization process and equipment, …)
* Act as spokesperson for the sterilization process during customer audits & regulatory inspections (Notified Body, FDA, …)
* Be the first point of contact for questions regarding the sterilization process for associates and the sub-contractor. Provide training to sterilization operators and other stakeholders when needed
* Prepare and host the Quality Review Meeting with the sub-contractor and follow up on the open actions
* Support internal audits at the sub-contractor as sterilization expert
Profile Description
* Master’s degree in (Bio)Engineering, biology and/or microbiology or equivalent by experience
* Detailed knowledge of sterilization processes (ETO, moist heat and irradiation), validation approaches and the related equipment
* Knowledge of the European and ISO standards related to Sterilization (EN ISO 11135; EN 285; ISO 17665; EN ISO 11138)
* Ability to work well in a team environment and foster cross-functional collaboration
* Self-starter and committed to adhering to deadlines
* Strong analytical skills
* Strong problem-solving skills
* Knowledge of statistical techniques
* Quality mindset and attention to detail