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Barden are partnering with our client, a lead in biopharmaceutical manufacturing space to source a Facilities Specialist – Cleaning Validation Technical Specialist in Dublin. This role will play a key part in operations and in special projects which being at the forefront of maintaining the cleanliness and integrity of our biological bulk drug substance (BDS) manufacturing processes. Your expertise will be crucial in supporting the design, start-up, and routine commercial manufacturing of our cutting-edge facility.
The Opportunity
- Master Plan Maintenance: Keep the Cleaning/Validation Master Plan up-to-date to support our multi-product drug substance manufacturing facility.
- Cleaning Strategy Development: Innovate and implement cleaning strategies for both fixed and mobile equipment.
- Cycle Optimization: Develop and optimize cleaning-in-place (CIP) cycles for buffer and media preparation systems, bioreactors, downstream equipment, parts washers, and other process equipment.
- Protocol Execution: Generate and execute detailed cleaning validation protocols.
- SOPs and WIs: Contribute to the creation and updating of Standard Operating Procedures (SOPs) and Work Instructions (WIs) to ensure effective cleaning sampling activities.
- Monitoring Support: Assist in the ongoing cleaning monitoring program to maintain high standards of cleanliness.
The Person
- Cleaning Validation Expertise: In-depth knowledge of cleaning validation principles, practices, and regulatory requirements, particularly in the pharmaceutical or biotechnology industries.
- cGMP Knowledge: Strong understanding of current Good Manufacturing Practices (cGMP) and how they apply to cleaning validation.
- Regulatory Knowledge: Familiarity with regulatory guidelines from agencies such as the FDA, EMA, and other relevant bodies.
- Degree: A bachelor’s degree in a relevant field such as Chemistry, Biochemistry, Chemical Engineering, or a related discipline.
- Team Collaboration: Experience working closely with departments such as Process Development, Engineering, Quality, and Regulatory Affairs.
