Kelly Services are recruiting for a Senior Validation Engineer for a Dublin based pharmaceutical company on a temporary basis until the end of December 2021.
As a validation engineer, you will be responsible Leading a Cross Functional Team to ensure that the Validation Activities associated with your allocated area in a Sterile Manufacturing Facility are in compliance with Division Quality System requirements and recognised international standards.
- Development of Validation Plans
- Ensure all aspects of Validation adhere to required policies and procedures, including safety and training.
- Ensure that the Site meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards.
- Pre-approve and post-approve validation protocols and assessments from a quality system documentation perspective.
- Participate as required in project activities.
- Liaise with Engineering and external vendors regarding equipment User Requirement Specifications , Factory Acceptance Tests to ensure the QBD principles are being followed.
- 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.
- A third level qualification in Science, Engineering or a relevant Quality discipline.
- Minimum 4-6 years experience in a similar role.
- Third level qualification in Science, Engineering or a relevant Quality discipline.
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As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.