Description
Our client is a leading European manufacturer of Biotech products.As part of a fast track project to validate a fill/finish large scale cell culture line - they are looking for a couple of experienced validation professionals with specific experience in validating part of the label and pack line. One position is working with semi-automated and manual packaging equipment for 3 months under ISO standards. The other is a 6 month contract working with similar equipment on the new pen product under GAMP regulations.
Must have experience of full lifecycle validation of manual and semi-automatic labelling and packaging equipment
. One position is to run a three month fast track project with immediate start (no summer vacation) related to validation of manual and semi-automatic label and packaging lines to be ISO certified in conjunction with new product launch of Factor - products.
The second job is a project of labelling and packaging of a second generation pen which also is a fast track project to run starting around July and running approx. 6 months. Also this project is for manual and semi-automatic label and packaging lines for a second generation pen device.
The majority of the work will be in the hand of the external validation engineer and therefore this requires the external validation engineer to have hands on experience and be very familiar with L&P qualification as well as have insight in the technical aspects of that area, e.g. knowledge of vision control systems, barcode readers, labelling machines and packaging lines and also knowledge and experience in establishing test criteria`s, risk assessments as well as preparing requirements traceability matrixes and validation project plans and protocols. The person`s must be highly motivated and have very high drive to accomplish assignments in time and indeed be able to work independently. Further, skills in communication across all levels required as the project reaches out in the entire organisation and as the projects are fast track, flexibility with regards to work hours a must as when it comes to execution time long days and weekends will be utilised.