We are delighted to partner with a well-known and established pharmaceutical company based in Wicklow, on a permanent Validation Engineer.
This is a great role that would see you work as part of a wider Quality & Regulatory function, with a focus on performing and executing the validation and qualification duties for all projects across the site.
As Validation Engineer, you will be responsible for:
* Preparation of Installation Qualification and Operations Qualification (IQ and OQ) protocols for all new engineering projects and liaise with the relevant Q.A. personnel to define the requirements of the protocols.
* Execution of IQ and OQ qualification/ validation tests.
* Complete qualification/ validation reports and summary reports and submit them to relevant Q.A. for approval.
* Advise relevant Q.A. personnel of the validation requirements for the Engineering Department.
* Represent the Engineering Department in the Validation Group Meeting and act as the point of contact in the Engineering team for Validation/Quality issues.
* Review documentation written by members of the Engineering Department to ensure that they adhere to the Validation protocols and Company policies.
* Act in an advisory capacity for the Engineering Department on all quality/ validation issues for specific projects.
* Liaise with Project Engineers and relevant Q.A. personnel to complete project documentation within defined time frames.
* Complete and update a library for validation documentation/ guidelines.
* Maintain the Change Control System for the Engineering Department.
* Policy and decision maker for Calibration and Metrology while complying with GAMP Guidelines and Good Weigh Practice.
Education and Experience required:
* Degree in a Scientific/Engineering discipline
* 4 years + experience in a Validation position within the pharmaceutical, biotech or medical device company
This is a hybrid role, with 3 days per week required on site.
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