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Validation Engineer
2 months ago
Job Title - Engineer
Location - New Albany, OH
Duration - 6+ months initial contract with extension.
Shift hours- 8 AM - 5 PM EST
Description:
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 Amgen Ohio's computer systems validation.
1. Perform Deviations, CAPA, Change records for DTI computer systems (E.g: MES, SCADA, ASRS, ServiceNow, QBAS, SAP/ERP, Serialization, etc).
2. Provide support to system owners on completing Design Spec, URS, Traceability, IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification) draft copies.
3. Provide support on completion of 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. Ensures that systems are maintained in a compliant manner according to the DTI quality systems standards.
7. Support regulatory inspections and internal audits as required.
Academic/Technical Qualifications:
1. Bachelor’s Degree in a science or Engineering discipline required.
2. 5+ years relevant experience in computer system validation (E.g: MES, SCADA, Building Management system (BMS, QBAS), Serialization, QC systems).
Top 3 Must Have Skill Sets:
1. Experience with testing tools (ALM, or Kneat or ValGenesis).
2. Experience with ServiceNow (Change Module), Track wise (CAPA, Deviations, Change), Veeva document management, CAPA, Deviations, Change Management.
3. Knowledge of cGMP regulations and guidelines including but not limited to U.S. code of Federal Regulations 21 CFR Part 11 and Part 211.
4. Understanding of industry standards and best practices for computer system validation such as GAMP 5.
