Website Asset Recruitment
ref # 13846
Join our client at their new state of the art single use multi-product biotech facility in Co. Meath. This facility will manufacture enzyme replacement and antibody-based therapies. 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.
This role shall be a combination of hands-on execution in the field while supporting the CQV lead in standing up the sustaining CQV program. The candidate will report into the Site CQV Lead.
• 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 Company products to site
• Support the planning of the site activities for a new capital project to bring new Company products to site
• Support the development of Standard Operating Procedures for the sustaining CQV programme
• 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.
Qualifications, Skills & Experience:
• Level 8 degree in a Science, Engineering or Other related Technical discipline
• 3+ years’ experience in a similar role within the pharmaceutical or biotech industry
• 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