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Cleaning Validation Engineer, Dublin South
Location: Dublin South, Ireland
Job Category:
EU work permit required: Yes
Job Reference: 5084728_1749464905
Job Views: 6
Posted: 09.06.2025
Expiry Date: 24.07.2025
Job Description:
Global Biotechnology company based in south Dublin, Ireland – looking for a Cleaning Validation Engineer.
The successful candidate will be responsible for ensuring that the Cleaning Validation activities associated with the Sterile Vial and Syringe Manufacturing Facility are in compliance with Division Quality System requirements and recognized international standards.
The role:
* Development of Cleaning Validation Strategy, Validation Plans, Protocols, and Reports for all cleaning and sterilization equipment and processes for a Sterile Fill Finish Facility.
* Ensure all aspects of Cleaning Validation adhere to required policies and procedures, including safety and training.
* Load Configuration and cycle development Cleaning Validation and Performance Qualification.
* Pre-approve and post-approve vendor protocols and assessments from a quality system documentation perspective for CIP, COP, Parts Washers, and Ultrasonic Baths used to support Sterile Vial and Syringe Manufacturing.
* Take swabs and rinse samples and perform laboratory studies to support cleaning validation studies on site.
* Assist in the development of any existing Validation program to ensure continued compliance to the necessary regulations. Input to site Validation Guidance Documents.
* Collate and report on relevant Validation data / matrices.
* Assist in deviation and exception resolution and root cause analysis.
Have You:
* A third level qualification in Science, Engineering, or a relevant Quality discipline.
* Cleaning Validation Experience essential: Minimum 4+ years' experience in Cleaning Validation.
* Clean-room Experience an advantage.
* Problem-solving ability and excellent oral and written communications skills.
The successful candidate must have an eligible working VISA in Ireland or an EU passport.
Berkley Life Science & Engineering is a specialist consultancy, recruiting professionals for organizations throughout Ireland, UK & Europe; for more information go to www.berkley-group.com
If you would like to discuss this vacancy further or your career options in confidence, please contact Aleksas Kremenskas at +353 (0) 87 2727949 or send your profile to [emailprotected]
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