Headcount Solutions is seeking a CQV Engineer for our client’s new biotech facility in Meath. The initial capital project to build the plant is nearing completion and the site is in the process of standing up a sustaining CQV program.
The role shall be a combination of hands-on execution in the field while supporting the CQV lead in standing up the sustaining CQV program.
· Work with the sustaining teams involved in change controls to develop and execute test protocols.
· Work with the CQV Lead to support the close out of the initial Validation Master Plan used to build the site.
· Support the development of Validation Templates and the planning of the site activities for a new capital project to bring new products to site.
· Support the development of Standard Operating Procedures for the sustaining CQV program.
· Support the development of training materials to help build CQV capabilities across the site.
· Co-ordinate the day-to-day management of contractors when qualification activities are outsourced e.g. Temperature Mapping, HVAC requalification, Autocalve requalification etc.
· Level 8 degree in a Science, Engineering or other related technical discipline.
· Experience developing validation documentation.
· Experience executing validation protocols.
· Experience closing out validation activities and writing validation reports.
· Project management experience is advantageous.
· Ability to analyse data and make recommendations.
· Experience in working with cross functional teams.
· Excellent report, standards, technical writing skills.
For further information, please contact Mick on 086-0435195 or forward details in confidence to [email protected]