Validation Engineer

Location: Slovenia (East of Maribor) – Onsite/remote hybrid

Start Date: End May/early June

Duration: 6-9 months

Time commitment: FTE

Title: Process/cleaning validation engineer

Description: The client needs a team of validation engineers to perform the process and cleaning validation activities for a biologics production plant which is scheduled to have first batches in October. The team would be writing process and cleaning validation protocols, ensuring the correct pre-requisites are met, the right sampling is performed, set up hold-time, resin, re-use, etc. studies, writing validation reports and help to explain/defend deviations. The candidates must have biologic process and/or cleaning validation related experience specifically with mammalian cell processes or microbial fermentation processes using stainless steel equipment/bioreactors. For the mid-to-senior level roles that candidates must have ability to confidently drive decisions and perform the activities effectively.