Description
Location; Dublin, IrelandDuration; Initial 6 month contract
Our biopharmaceutical client requires a Validation Engineer with vial/syringe filling and formulation experience.
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.
Major Responsibilities:
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 (URS’s), Factory Acceptance Tests (Fat’s) 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.