Overview
On Site
Full Time
Skills
Systems Design
Documentation
Testing
Regulatory Compliance
Business Systems
Information Technology
GxP
Good Manufacturing Practice
Corrective And Preventive Action
ServiceNow
SAP ERP
URS
IQ
OQ
PQ
Test Scripts
Application Lifecycle Management
Quality Management
Auditing
Science
Computerized System Validation
MES
SCADA
Management
Quality Control
Job Details
Primarily responsible for ensuring adherence to computer validation standards and procedures for computer related systems. Responsibilities include participation in system design, preparation of test protocols, analysis of test results and preparation of summaries. Provides guidance and sets standards in producing quality documentation, serves as the liaison between the IS and Quality functions, provides testing and IT compliance guidance, and provides timely and effective response and follow-through in the resolution of IT Quality/Project compliance issues.
This role is for a strong background in IT Business systems validation, IT Automation systems validation, ensuring that our Information technology systems and processes meet regulatory requirements and industry standards, particularly within the framework of GxP (Good manufacturing Practice) in projects. Integrates a variety of systems technologies to provide systems related solutions to meet business needs. Supports the creation and maintenance of a Client Ohio's computer systems validation.
1. Perform Deviations, CAPA, Change records for Technology computer systems (E.g: MES, SCADA, ASRS, ServiceNow, QBAS, SAP/ERP, Serialization, etc).
2. Provide support to system owners on completion of Design Specifications, URS, Traceability, IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification) draft copies.
3. Provide support to complete the validation deliverables as required per the project.
4. Develop and execute test scripts in ALM, Kneat test tools to support system owners/IT Application Owners.
5. Ensure and track computer systems periodic reviews and periodic access reviews are completed as per schedule to maintain system maintenance phase.
6. Perform system periodic reviews for Computerized systems, Automation systems.
7. Familiar with validating SCADA, MES, PI Factory Talk Historian, Serialization systems.
8. Ensures that systems are maintained in a compliant manner according to the Technology quality systems standards.
9. Support regulatory inspections and internal audits as required.
cademic/Technical Qualifications:
1. Bachelor's Degree in a science or Engineering discipline required.
2. 7+ years relevant experience in computer system validation (E.g: MES, SCADA, PI Factory Talk Historian, Building Management system (Client, QBAS), Serialization, QC systems).
This role is for a strong background in IT Business systems validation, IT Automation systems validation, ensuring that our Information technology systems and processes meet regulatory requirements and industry standards, particularly within the framework of GxP (Good manufacturing Practice) in projects. Integrates a variety of systems technologies to provide systems related solutions to meet business needs. Supports the creation and maintenance of a Client Ohio's computer systems validation.
1. Perform Deviations, CAPA, Change records for Technology computer systems (E.g: MES, SCADA, ASRS, ServiceNow, QBAS, SAP/ERP, Serialization, etc).
2. Provide support to system owners on completion of Design Specifications, URS, Traceability, IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification) draft copies.
3. Provide support to complete the validation deliverables as required per the project.
4. Develop and execute test scripts in ALM, Kneat test tools to support system owners/IT Application Owners.
5. Ensure and track computer systems periodic reviews and periodic access reviews are completed as per schedule to maintain system maintenance phase.
6. Perform system periodic reviews for Computerized systems, Automation systems.
7. Familiar with validating SCADA, MES, PI Factory Talk Historian, Serialization systems.
8. Ensures that systems are maintained in a compliant manner according to the Technology quality systems standards.
9. Support regulatory inspections and internal audits as required.
cademic/Technical Qualifications:
1. Bachelor's Degree in a science or Engineering discipline required.
2. 7+ years relevant experience in computer system validation (E.g: MES, SCADA, PI Factory Talk Historian, Building Management system (Client, QBAS), Serialization, QC systems).
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