Requirements: English
Company: Arcadis
Region: Leuven , Flanders
Job Summary
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.
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 the company 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 Terumo 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
- Masters 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