· Draft, lead reviews and approval of Engineering Commissioning protocols (FAT, SAT etc.) and validation protocols (IOQ and PQ protocols) to support new manufacturing line installation.
· Support Execute the IOQ and PQ protocols.
· Have expertise in equipment validation and Computer System Validation
· Manage, track and lead closure of discrepancies and deviations of executed validation protocols
· Draft and lead reviews and approval of and validation summary reports
· Support vendor activities on Site during installation, commissioning, SAT and pre-IOQ protocols executions.
· Provide technical and compliance expertise to write SDLC documentation in accordance with local procedures, templates, regulatory requirements (21 CFR Part 11, 211, 820), and IT Security Standards. Track and execute computer system Periodic Reviews, User Account Reviews, and other computer system compliance processes as assigned.
Validation Protocols, Associated SOPs, Part 11 Risk Assessments, Verification Plans, Test Scripts).Work with the data integrity team to ensure compliance in creation and execution of
Job Type: Contract
Salary: $40.00 to $49.00 /hour
he City of St. Louis Department of Health will continue to update information on the website. We have also worked with the Centers for Disease Control and Prevention to provide additional information directly from the CDC in relation to COVID-19.
This Job Is Ideal for Someone Who Is:
- Dependable -- more reliable than spontaneous
- People-oriented -- enjoys interacting with people and working on group projects
- Detail-oriented -- would rather focus on the details of work than the bigger picture
- Monday to Friday
- No weekends
- 8 hour shift
- Only full-time employees eligible
- Temporarily due to COVID-19