QC Support Engineer

JSR Life Sciences is a global company that is built on more than 60 years of expertise in the field of polymer chemistry and more than 30 years of expertise in the field of Life Sciences. JSR Micro NV in Leuven is making innovative products for both the semiconductor and the life sciences industry.

Using a variety of integrated, leading-edge technologies, JSR Life Sciences Leuven provides materials that contribute to the manufacturing process of biopharmaceuticals

Our Life Sciences activities in Leuven started in 2011 with fermentation and purification of JSR's propriety protein A Ligand. In 2017 we started the new production line for Amsphere. This resin is a next generation Protein A chromatography resin for advanced protein separation in downstream processing of therapeutic antibodies manufacturing. Our core values towards the biopharmaceutical industry are uncompromised customer orientation, quality and business continuity.

For our Life Sciences production activity in Leuven we are currently looking for a:

We are seeking an experienced and motivated QC Support engineer to expand our quality control department. In this role, you will ensure the development, validation, and optimization of QC methods while maintaining compliance with quality standards. You will provide technical support for test methods, manage deviations, leading root cause investigations and implement corrective and preventive actions. By streamlining workflows, qualifying new equipment, and driving continuous improvement, you will contribute to efficient, reliable, and high-quality QC operations.

Your main responsibilities will be:

• Driving change management within the QC laboratory
• Developing, transferring, and optimizing innovative QC methods.
• Execute and report on QC method validations (validation strategy, protocols, executionand reports)
• Driving excellence in quality by documenting, managing, and following up on deviations within QC
• Leading root cause analyses and implementing effective corrective and preventive actions (CAPA).
• Acting as the go-to point of contact for technical questions related to test methods, execution, and data processing
• Safeguarding the validated state of methods and ensuring compliance at all times.
• Streamlining and optimizing operational excellence to enhance safety, quality and to reduce costs.
• Supporting the qualification and integration of new equipment.
• Upholding the highest quality standards within the organization.
• Back up for routine QC testing if needed

• You have obtained a scientific Master's degree or have equivalent experience.
• You have at least three years of experience in supporting a QC environment, preferably in the pharmaceutical or life sciences industry or you have a high scientific expertise obtained during a PhD, using (bio-)analytical techniques
• You have practical and theoretical knowledge of key techniques within microbiological evaluation (e.g. plating & viability) , ligand-binding assays (e.g. SDS-PAGE, endotoxin testing and ELISA) and physiochemical evaluations (pH, conductivity, HPLC)
• Besides strong analytical skills, you excel at problem-solving and like to deep dive into details.
• You enjoy working independently, adapt quickly to change, and are comfortable in an agile work environment
• You preferably have practical knowledge of equipment (re)qualification and experience with (method) validation and improvement projects.
• GLP and GMP are familiar concepts to you.
• Integrity, quality and respect are your core values
• You possess strong communication skills and are fluent in both Dutch and English.

Your flexible and act as a backup for routine testing if necessary

We offer a multi-cultural environment where the boundaries of technology are challenged every day.

Based on your level of experience and technical knowledge we set up the position to give you the challenge and growth opportunities you need. We ensure growth opportunities by on-the-job learning and supporting your development with training and coaching.

We offer you an attractive salary package in line with your experience with many extra-legal benefits such as meal vouchers, a bonus, a leasebike, , 38 holidays per year and a life and hospitalisation insurance (including dental plan). Sports/culture and eco cheques are also included I this package.