A leading global Biopharmaceutical company dedicated to supporting customers and their businesses in ever better ways. This organisation delivers quality medicines and vaccines, complemented by diagnostic products, genetic tests, biodevices and a range of services. Selling into over 100+ countries with over 10,000 employees, this organisation is one of the largest healthcare organisations in its defined sector. Expanding heavily here in Ireland with the acquisition of several manufacturing sites, this business has invested heavily in its Biologics flagship manufacturing operation here in particular and currently require a Validation Manager to head up a newly formed dept for the organisation.
- As a Validation Manager, you will report into the Director of Manufacturing and will be responsible for building and leading the validation group that supports start-up, commissioning, and validation activities at this new site, as well as maintaining activities on the current sites.
- Responsible for and directs qualification of equipment (process and analytical), utilities, software, shipping, and cleaning validation.
- CQV Subject Matter Expert, preferably with experience of FDA and EMA requirements to ensure the program is administer and complies with regulatory guidelines.
- Manage CQV Strategy and project timelines and deliverable, budget, and resources.
- Manage team of C&Q activities throughout the project lifecycle.
- Strong experience with Validation Master Plan, Commissioning Master Plan, project procedures and commissioning and qualification protocols (SAT/Commissioning, IQ and OQ)
- You will be degree qualified in a in Engineering or related technical discipline
- The ideal candidate will have 8-10 years' experience in commissioning and qualification activities for pharmaceutical facilities
- Previous C&Q Management is advantageous
- Strong knowledge of ISPE and ASTM E2500
To discover more about this opportunity, apply now or contact Déanna Healy at HRM on +353 87 636 9263 for a confidential discussion.