Job opening - Contamination Control Engineer in Woluwé-Saint-Lambert

summary

woluwé-saint-lambert, brussels hoofdstedelijk gewest
permanent
full-time

job category
engineering

job details

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!

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Are you ready to be the guardian of product safety and quality in a world-leading biopharma environment?

key responsibilities
Your Role in contamination control
As the Contamination Control Engineer, you will be the key expert responsible for implementing, maintaining, and continuously improving the microbial control strategy across our manufacturing site. You will drive quality excellence by ensuring all contamination risks are minimized, investigated, and addressed effectively.
Key Responsibilities:
- Microbial control systems: 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.
- Quality & compliance:
- 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.
- Transversal activities & support:
- 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).
skills
- Process Monitor
- Program Process Monitoring
- Process Control
- Process Management
- Process Analysis
- Training Activities
- Site Inspection
- Auditing
- Analytical
- Process Control Systems
qualifications
We are looking for a dedicated professional who brings a strong scientific background and hands-on pharmaceutical experience.
Your qualifications:
- Education: Master’s degree or equivalent in Pharmaceutical Sciences, Biotechnology, Life Sciences, or a related field.
- Experience: minimum of 3 years of experience within the pharmaceutical industry, specifically in manufacturing and/or quality operations.
education
- Masters or equivalent

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