Description
A Global Biotech organisation currently requires an experienced Cleaning Validation Engineer to work at their facility in Ireland.As a Cleaning Validation Engineer, you will be responsible for ensuring that the cleaning validation activities associated with their sterile vial and syringe manufacturing facility is in compliance with Division Quality System requirements and recognised international standards.
Major Responsibilities
•Development of Cleaning Validation Strategy, validation plans, protocols and reports for all cleaning 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 Verification and Cleaning Validation.
Ensure that the site meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards.
•Generate and execute protocols and assessments from a quality system documentation perspective for CIP, Parts Washers and Ultrasonic Baths used to support Sterile Vial and Syringe Manufacturing.
•Participate as required in project activities.
•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.
•Develop and rollout validation training for the site on subjects assigned by the Site Validation Leader.
Experience/Background
•A third level qualification in Science, Engineering or a relevant Quality discipline.
•Extensive Parts, Equipment and Vessel Cleaning Experience essential
•Experience in Time Pressure Filling CIP an advantage
•Component Preparation Commissioning Experience an advantage
•Minimum 2 years’ experience in a similar role.
Education Requirements
•A third level qualification in Science, Engineering or a relevant Quality discipline.