Website I.T. Solutions, Inc.
I.T. Solutions, Inc.
Company : I.T. Solutions, Inc.
Sr. Computer Systems Validation Analyst
Foster City, CA (Onsite)
Long Term Rolling Contract
- Plan, lead, and execute the validation efforts for SCADA, Rockwell Factory Talk, PLC's and Ignition Talk
- Create/write validation documentation (VP/URS/FS/DS/Trace Matrix/Risk Assessment/IQ/OQ/PQ, etc.) for process control systems.
- Author documents related to GxP Systems
- Draft Requirements and computer systems validation documents using GAMP 5
- Execute test protocols for the software validation.
- Initiate and execute change management for existing qualified systems.
- Develop change management record, create or revise documentation if required, and execute implementation tasks.
- Use understanding of 21 CFR part 11 and Annex 11 and how these regulations relate to a process control system
- Maintaining the project plan/schedule to meet deliverable commitments.
Deliverables:
- User and Configuration Specifications
- System Impact Assessments
- Risk Assessments
- Installation Qualification Protocols
- Operation Qualification Protocols
- Performance Qualification Protocols
- Traceability Matrix
- Summary Reports Standard Operating Procedures
- Authoring Change Controls
- Authoring and executing test protocols
- Managing Issue Reporting, Deviations and related CAPAs
The salary range provided for this contract role represents our good faith estimate for this position. Within the range, individual offers will vary based on the selected candidate's experience, industry knowledge, technical and communication skills, location and other factors that may prove relevant during the interview process (W2 or C2C). In addition to compensation, the company provides eligible W2 employees with a comprehensive and highly competitive benefits package.
I.T. Solutions, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.