Responsibilities

• 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 for a new capital project to bring new site products to site
• Support the planning of the site activities for a new capital project to bring new site 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, Autoclave requalification etc.
• Although this is a site-based role, COVID-19 restriction will require the candidate to work from home when possible

Qualifications & Education

• 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 a plus
• Ability to analyse data and make recommendations
• Experience in working with cross functional teams
• Excellent report, standards, technical writing skills
• Proficiency in Microsoft Office suite and job-related computer applications required

To apply contact Martin Lynch on 087-344 3581.

Email CVs to mlynch@mile.ie