Kelly Services currently have a number of Validation Engineering jobs available across the life science industry, both pharmaceutical and medical device. These roles are based with high profile clients in multiple occasions throughout Ireland, including Dublin, Galway, Cork and the midlands. The ideal candidate would, as a minimum, have:
- 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 (URSs), Factory Acceptance Tests (Fats) 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 5 years' experience in a similar role. Education Requirements
- Sterilisation experience i.e. in autoclaves, lyophilizer/freeze drying
Kelly Services are acting as an Employment Agency in relation to this role. Should you choose to apply, your information will be processed in accordance with Kelly's Privacy Statement.
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.