Duration: 6+ months 40 hours per week
Start Date: End of July/Early August
Job Description:
Client is getting facility up and running and has a team of folks identified for CSV and System implementation activities who will be starting work at the end of July/early August. Would like to bring in an experienced CSV Review/ CSV Quality Review person who can assist with the review and oversight of the protocols the validation folks are generating. Main System being implemented is their CMMS which is Blue Mountain so having experience there is needed, additionally, BMS System (Siemens BMS), EMS is SCADA based, PLC to a SCADA ignition (Siemens or AB is OK), Veeva QMS Software, and familiarity with PI historians (Still TBD on which they choose but would like some expeirence there). Everything is done in KNEAT so looking for experience there as well. We are looking for candidates who come with experience reviewing protocols and providing quality oversight. 75% of the job is the review work/supporting the teams generating protocols, the other 25% is help with execution, oversight of change controls, investigating deviations that arise and writing corresponding deviation reports. Looking for 5-8 years of relevant hands on experience working in review roles in a start up (Brownfield/Greenfield) environment. We are NOT looking for candidates coming with a background in laboratory and process equipment. This role is strictly on the CSV/Automation SDLC oversight side.
Skills:
- CSV, Automation, Review/Oversight, KNEAT, BMS, Blue Mountain, PLC, SCADA, Veeva, Start Up
Education:
- B.S. in relevant field preferred, but experience can outweigh the degree
PA: CSV Oversight Contractor (237678)
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