Merck
- Long controls testing cycles.
Specialist, Engineering
- Global NPI line setups at Merck. Everything from working with the architectural consulting firm to build the building, all the way to setting temperature parameters on the line machines for the production line. - Works mostly on drug product equipment like filling syringes, tubs, etc. - Most painful part of the process for her is automation testing cycles. E.g. automation team has a much more extensive suite of validation, and she will be blocked for 2 weeks waiting on them to finish testing, then have to REDO her test. She is generally in critical path so delays for her are delays of overall product timelines. - Mentioned additional issue about people not liking the digital paperwork system they are using (Kneat). Software not smart enough to allow for small changes without FDA exception (e.g. wrong door label in test, etc.). - They use DeltaV (Emerson) as their line control system at Merck.