What are the responsibilities and job description for the Validation Engineer position at Katalyst Healthcares & Life Sciences?
Responsibilities :
Responsible for preparing and executing test documentation for GMP computerized systems as well as providing support in the troubleshooting of issues during test execution.
You should have excellent understanding of 21 CFR Part 11, ICH standards, EMA and FDA (GxP) regulations, and GAMP methodologies.
Coordinate with multi-disciplinary validation team and be responsible for the validation of automated equipment and control systems
Create and modify validation documentation including but not limited to: User Requirements Specifications (URS) Design Reviews (DR) Criticality assessments CSV protocols (SAT, IQ, OQ, PQ) which verify if the system is compliant to regulatory and client requirements
Reports which summarize the results of the protocol executions
Exception reports which identify defects or issues during test execution Review vendor documentation
Requirement Specification document review and approvals
System Implementation Plan Review
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
gR Implementation Approvals
Retirement Plan Revew
Requirements:
Requirement document
Validation/Test Plan
Requirement Traceability Matrix
Change Requests
Impact assessment document
Test/Validation Summary Report
Responsible for preparing and executing test documentation for GMP computerized systems as well as providing support in the troubleshooting of issues during test execution.
You should have excellent understanding of 21 CFR Part 11, ICH standards, EMA and FDA (GxP) regulations, and GAMP methodologies.
Coordinate with multi-disciplinary validation team and be responsible for the validation of automated equipment and control systems
Create and modify validation documentation including but not limited to: User Requirements Specifications (URS) Design Reviews (DR) Criticality assessments CSV protocols (SAT, IQ, OQ, PQ) which verify if the system is compliant to regulatory and client requirements
Reports which summarize the results of the protocol executions
Exception reports which identify defects or issues during test execution Review vendor documentation
Requirement Specification document review and approvals
System Implementation Plan Review
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
gR Implementation Approvals
Retirement Plan Revew
Requirements:
Requirement document
Validation/Test Plan
Requirement Traceability Matrix
Change Requests
Impact assessment document
Test/Validation Summary Report
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