Katalyst CRO
Sr. Computer Systems Validation Engineer
Katalyst CRO, Foster City, California, United States, 94420
Sr. Computer Systems Validation Engineer
Apply for the Sr. Computer Systems Validation Engineer role at Katalyst CRO.
Summary Plan, lead, and execute the validation efforts for SCADA, Rockwell Factory Talk, PLC’s and Ignition Talk. Author and draft validation documents using GAMP 5, and execute test protocols for software validation. Initiate and execute change management for existing qualified systems, developing records and revising documentation as required. Apply knowledge of 21 CFR Part 11 and Annex 11 to process control systems, maintaining project plans and schedules to meet deliverable commitments.
Responsibilities
Plan, lead, and execute validation efforts for SCADA, Rockwell Factory Talk, PLC’s and Ignition Talk
Author documents related to GxP systems
Draft requirements and computer systems validation documents using GAMP 5
Execute test protocols for 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
Apply understanding of 21 CFR Part 11 and Annex 11 as they relate to process control systems
Maintain the project plan/schedule to meet deliverable commitments
Roles & Responsibilities
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 of Change Controls
Authoring and executing test protocols
Managing issue reporting, deviations and related CAPAs
Education & Experience Minimum 5 years of experience required.
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Quality Assurance
Industries Biotechnology Research and Civil Engineering
Referrals increase your chances of interviewing at Katalyst CRO by 2x.
Get notified about new System Validation Engineer jobs in Foster City, CA.
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Summary Plan, lead, and execute the validation efforts for SCADA, Rockwell Factory Talk, PLC’s and Ignition Talk. Author and draft validation documents using GAMP 5, and execute test protocols for software validation. Initiate and execute change management for existing qualified systems, developing records and revising documentation as required. Apply knowledge of 21 CFR Part 11 and Annex 11 to process control systems, maintaining project plans and schedules to meet deliverable commitments.
Responsibilities
Plan, lead, and execute validation efforts for SCADA, Rockwell Factory Talk, PLC’s and Ignition Talk
Author documents related to GxP systems
Draft requirements and computer systems validation documents using GAMP 5
Execute test protocols for 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
Apply understanding of 21 CFR Part 11 and Annex 11 as they relate to process control systems
Maintain the project plan/schedule to meet deliverable commitments
Roles & Responsibilities
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 of Change Controls
Authoring and executing test protocols
Managing issue reporting, deviations and related CAPAs
Education & Experience Minimum 5 years of experience required.
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Quality Assurance
Industries Biotechnology Research and Civil Engineering
Referrals increase your chances of interviewing at Katalyst CRO by 2x.
Get notified about new System Validation Engineer jobs in Foster City, CA.
#J-18808-Ljbffr