What are the responsibilities and job description for the CSV Engineer position at IT Minds LLC?
Role: Senior level CSV Engineer (15-20 years’ experience)
Location: New Jersey (100% onsite)
Must Skills – Waters EMPOWER Data Management Systems, GAMP 3-4 ISP Guidelines different GAMP Category, 3-5 years Isolators, Documentation skills, clear and concise protocol writing attention to detail. Someone that can drive documents to completion, fast-paced 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
Location: New Jersey (100% onsite)
Must Skills – Waters EMPOWER Data Management Systems, GAMP 3-4 ISP Guidelines different GAMP Category, 3-5 years Isolators, Documentation skills, clear and concise protocol writing attention to detail. Someone that can drive documents to completion, fast-paced 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
