Overview
Skills
Job Details
These positions will focus on utilizing skill sets and experience in Cleaning Validation for start-up, validation of water generation systems, clean steam generation systems, distribution systems, storage tanks, and process gas/air systems.
Ideal candidates would have experience in the full Cleaning Validation lifecycle including specification review, vendor document review, document field verification, commissioning document drafting, commissioning execution, and summary report drafting.
Deviations for Cleaning Validations.
Sample testing and protocol writing.
Must be able to work in a fairly fast-paced environment.
Greenfield experience is a big plus.
Experience with CIP/COP Cleaning Validation.
The small parts they work with are parts washers and autoclaves.
They will ask about the size of bioreactor tanks they have had experience with.
Swab sampling
They have 700 CIP circuits
DSM 2 is almost complete; SOP's are almost complete but still need some writing.
They will ask a number of questions that may not be surrounding Cleaning Validations ex. Process, upstream, downstream, design etc due to having to be cross functional and speaking with these groups this helps them see who goes with what team.
KNEAT experience and how they have used it to execute, use data etc.
Gowning up will happen more so as product is coming in
There are other groups looking for CQV and CTU experience as well.
Looking for Mid-level to Senior-level (5-20+ yrs. exp).