CSV Engineer
CSV Engineer
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Job Description
Role: Senior level CSV Engineer (1520 years experience)
Location: New Jersey (100% onsite)
Must Skills Waters EMPOWER Data Management Systems GAMP 34 ISP Guidelines different GAMP Category 35 years Isolators Documentation skills clear and concise protocol writing attention to detail. Someone that can drive documents to completion fastpaced environment open communicator.
Trade Off Skill Chem Station Agilent SW Any LIMS Systems experience or data management system.
Plus Skills Chemistry Background would be huge GAMP 5 Ocea View (software that monitors room temperature humidity in the labs) Scan Stations (Bacteriology work take samples swabbing and testing on scan station)
SV Remediation EMPOWER SOFTWARE PLC Mnf Lab Equipment ROCKWELL.
Sterile and Vial Injectables
5 MNF LINES getting lines 1 and 2 going now lots of qualifications have been taking place in 2024
Liquid Chromatography
Titrators
Ovens
HPLC
Scada
Isolators etc
CSV Analytical Engineer person that understands CFR Part 11 accounting for Data Integrity
Stand Alone State. Moving off the network and to stand alone moving them to a new server connection once qualified
Protocol generation execution Gap Assessments and SOP Writing. Change Control Waterfall Methodology URS FAT SAT Trace Matrix RTM
Waters Empower III Feature Release 5 (Other systems used there is Lab Solutions Lab X)
Configuration Management CMMS Gap Analysis Periodic Reviews
Employment Type
Full Time
