- A new opportunity has arisen for the role of a CQV (Commissioning, Qualification and Validation) Engineer at our client’s pharmaceutical site in Co. Meath.
- The role is a combination of hands-on execution in the field while supporting the CQV lead in standing up the sustaining CQV program.
Core Duties and 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 products to site
- Support 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.
- Although this is a site-based role, COVID-19 restriction will require the candidate to work from home when possible.
Minimum Qualifications and Experience:
- Level 8 degree in a Scienece, 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
If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:
14 Danville Business Park, Kilkenny, Ireland
+353 56 77 90100
Please note, we do not require agency assistance with this role.