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Are you ready to be the guardian of product safety and quality in a world-leading biopharma environment? If you are a highly motivated life sciences professional with a passion for microbial control and a commitment to patient safety, then we have an exceptional opportunity for you at our state-of-the-art facility in Geel. At this company, located at Geel, we are dedicated to developing and manufacturing life-changing therapies. As our new Contamination Control Engineer, you will play a critical role in ensuring the integrity of our processes, cleanrooms, and utilities. This is more than just a job; it’s a chance to apply your expertise to safeguard the quality of our products and contribute to a healthier future. If you thrive on meticulous work, root cause analysis, and being the go-to expert in your field, read on!
Job Responsibility:
Ensure robust microbial control of process, cleanroom, and clean utility systems by setting up comprehensive monitoring plans and scientifically sound limits
Performing rigorous trend evaluations and defining necessary improvement actions
Delivering Performance Qualification (PQ) documents for clean utility and cleanroom systems
Performing trend evaluation and reporting of microbial data for all relevant systems
Act as coordinator and/or investigation leader for deviations related to process, clean utilities, or cleanrooms
Conduct (pre-)assessments of the microbial impact for proposed changes (Change Control)
Provide expert microbial information during deviation investigations to assess the impact on the final product
Elaborate and enforce the overall Contamination Control strategy across the business unit site at Geel
Actively participate in training and awareness sessions for the site regarding Contamination Control
Serve as the primary contact person for Contamination Control expertise
Participate in and support site inspections and audits by regulatory bodies
Provide essential Contamination Control support to site improvement projects (e.g., product launches, ramp-ups, accelerations)
Requirements:
Master’s degree or equivalent in Pharmaceutical Sciences, Biotechnology, Life Sciences, or a related field
minimum of 3 years of experience within the pharmaceutical industry, specifically in manufacturing and/or quality operations