Control contamination, enable breakthroughs-join the biotech frontier.
R&D Partners is seeking a CC Engineer to join our client's team in EU. This role focuses on ensuring microbiological control of cleanrooms and clean utility systems, managing deviations and change controls, and helping develop contamination control methods.
Please note that to be considered for this role you must have the right to work in this location.
Responsibilities:
Microbiological Control:
* Set up monitoring plans, establish limits, perform trend evaluations, and define improvement actions for process cleanrooms and clean utility systems.
* Deliver performance qualification documents for clean utility and cleanroom systems.
* Evaluate and report microbiological data trends for process cleanrooms and clean utilities.
Deviations and Change Controls:
* Act as coordinator or investigation leader for deviations related to process clean utilities or cleanrooms.
* Assess microbiological impact of proposed changes and provide relevant information for deviation assessments.
* Develop and elaborate on the overall contamination control strategy.
Transversal Activities:
* Participate in awareness and training sessions regarding contamination control.
* Serve as the contact person for contamination control expertise.
* Support site inspections, audits, and improvement projects, including new clinical product launches and ramp-ups.
Key Skills and Requirements:
* Master's degree or equivalent in Pharmaceutical, Biotech, or Life Sciences.
* Minimum of 3 years of experience in the pharmaceutical industry, specifically in manufacturing and/or quality operations.
* Strong knowledge of microbiological control and contamination control methods.
* Experience with deviation investigations, change controls, and performance qualifications.
For more information, please contact
Grant Van Schalkwyk
.
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists visit the 'Contact Us' page.
R&D Partners is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. R&D Partners is acting as an Employment Agency in relation to this vacancy.
By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data - https://www.r-