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!
We are looking for a dedicated professional who brings a strong scientific background and hands-on pharmaceutical experience.
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).
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.
We offer:
At Randstad Professionals, we recognize the value of your expertise and dedication. We offer a comprehensive and attractive benefits package designed to support your professional and personal well-being:
* Competitive Salary: A competitive gross salary, meticulously tailored to your level of expertise and experience.
* Net Allowance: An additional net allowance of €80 per month.
* Mobility Options: The opportunity for a company car (under specific conditions) including a fuel card (also for private use), or an attractive mileage reimbursement.
* Meal Vouchers: Meal vouchers valued at €140 per 20 working days.
* Eco Vouchers: Annual eco-cheques of €250.
* Statutory Benefits: Legal holiday allowance and a 13th month bonus.
* Work-Life Balance: 12 extra ADV/time off days per year.
* Health Coverage: Comprehensive hospitalization insurance via DKV.
* Professional Development: Access to numerous training opportunities to keep your skills sharp.
* Team & Culture: Participation in engaging company activities and events.
* Career Growth: Clear growth opportunities to further develop your career path within our organization.