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

200 systems

Testing for compliance standards, data migration of equipment to their on-server network.