Katalyst CRO
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Sr. CSV Engineer
role at
Katalyst CRO
Responsibilities:
Preparing and executing test documentation for GMP computerized systems, and providing support during troubleshooting issues during test execution.
Strong understanding of 21 CFR Part 11, ICH standards, EMA and FDA (GxP) regulations, and GAMP methodologies.
Coordinating with multi-disciplinary validation team and responsible for the validation of automated equipment and control systems.
Creating and modifying validation documentation including but not limited to User Requirements Specifications (URS), Design Reviews (DR), Criticality assessments, CSV protocols (SAT, IQ, OQ, PQ) to verify system compliance with regulatory and client requirements.
Creating and reviewing reports that summarize protocol execution results, exception reports that identify defects or issues, and vendor documentation review.
MES expertise is required.
Working from the Bothell location.
Requirement Specification document review and approvals.
System Implementation Summary Report Review.
Review and pre-approve ST/UAT Test Scripts in ALM.
Create, update RRA (Regulatory Risk Assessment) and obtain approvals.
Post execution review and post approvals in ALM.
CR Implementation Approvals.
Retirement Summary review.
Deliverables:
Requirement document.
Validation/Test Plan.
Requirement Traceability Matrix.
Change Requests.
Test/Validation Summary Report.
Seniority level Mid-Senior level
Employment type Full-time
Job function Engineering and Information Technology
Industries Civil Engineering
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Sr. CSV Engineer
role at
Katalyst CRO
Responsibilities:
Preparing and executing test documentation for GMP computerized systems, and providing support during troubleshooting issues during test execution.
Strong understanding of 21 CFR Part 11, ICH standards, EMA and FDA (GxP) regulations, and GAMP methodologies.
Coordinating with multi-disciplinary validation team and responsible for the validation of automated equipment and control systems.
Creating and modifying validation documentation including but not limited to User Requirements Specifications (URS), Design Reviews (DR), Criticality assessments, CSV protocols (SAT, IQ, OQ, PQ) to verify system compliance with regulatory and client requirements.
Creating and reviewing reports that summarize protocol execution results, exception reports that identify defects or issues, and vendor documentation review.
MES expertise is required.
Working from the Bothell location.
Requirement Specification document review and approvals.
System Implementation Summary Report Review.
Review and pre-approve ST/UAT Test Scripts in ALM.
Create, update RRA (Regulatory Risk Assessment) and obtain approvals.
Post execution review and post approvals in ALM.
CR Implementation Approvals.
Retirement Summary review.
Deliverables:
Requirement document.
Validation/Test Plan.
Requirement Traceability Matrix.
Change Requests.
Test/Validation Summary Report.
Seniority level Mid-Senior level
Employment type Full-time
Job function Engineering and Information Technology
Industries Civil Engineering
#J-18808-Ljbffr