Great opportunity for a Technical Specialist to join our team with our biotech client in Limerick to support the document preparation and execution activities for their Cleaning Validation Program.
Your responsibilities will include
o Generate/review/Approval of CV protocols,
o Generate Reports
o Maintain and update Cleaning Validation Plan
o Schedule of cleaning activities with Manufacturing
o Liaise with numerous departments
Your expeirence and education will include:
o BSc or BEng
o 3-5 years Biotech experience
o Experience in Validation specifically cleaning validation
o Experience in assessment of cleaning issues during study runs,
o Experienced Technical writer,
o Experience in Deviation/Change control writing,
o Capable of managing a large program, so project management skills would be necessary,
o An excellent understanding of how manufacturing/Cleaning Validation/Cleaning equipment works
o Good technical knowledge of BioTech equipment and the concepts of BioTech manufacturing.
o Have Troubleshooting and analytical mindset
o Experience in major start-ups where clean-into-service, coverage testing, baseline studies in commissioning area, and cleaning validation studies may be concurrent activities in different trains.
For full details of this role please contac Kathy on 021 4777329 or apply directly through this advert.