Great opportunity for a Cleaning Validation Engineer to join our team with our biotech client in Limerick to support the document preparation and execution activities for tthe initial qualification and validation of biotech faciilty specifically in Cleaning Validation.
Your responsiblities will include:
o Taking Cleaning Validation samples alongside Upstream/Downstream processing.
o Working closely with manufacturing to ensure the CIP/SIP and dirty holds are to the correct times and samples are taken.
o Shows focus & a consistence approach to the role and tasks.
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 Understanding of baseline studies for new equipment
o Experienced in coverage testing and clean-into-service
o Generate/review/Approval of CV protocols,
o Generate Reports
o Maintain and update Cleaning Validation Plan
o Schedule of cleaning activities with Manufacturing
Your education and experience will include:
o Third level degree: BSc or BEng
o 3-5 years Biotech experience
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.
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 Good technical knowledge of BioTech equipment and the concepts of BioTech manufacturing.
o Have Troubleshooting and analytical mindset
For full details on this role please contact Kathy on 021 4777329 or apply directly through this advert.