Job Title: Senior Validation Engineer
Location: New Albany, OH
Job Summary:
- Join our team as a Senior Validation Engineer, where you’ll play a crucial role in ensuring compliance with computer validation standards and procedures for computer-related systems. You’ll be involved in system design, test protocol preparation, test result analysis, and summary preparation. You’ll also provide guidance on quality documentation, serve as a liaison between IS and Quality functions, and offer testing and IT compliance guidance.
Job Responsibilities:
- Oversee deviations, CAPA, and change records for technology computer systems (e.g., MES, SCADA, ASRS, ServiceNow, QBAS, SAP/ERP, Serialization, etc.)
- Support system owners in completing Design Specifications, URS, Traceability, IQ, OQ, and PQ draft copies
- Assist in completing the validation deliverables as required per the project
- Develop and execute test scripts in ALM, Kneat test tools to support system owners/IT Application Owners
- Ensure and track computer systems periodic reviews and periodic access reviews are completed as per schedule to maintain system maintenance phase
- Support regulatory inspections and internal audits as required
Skills Required:
- Bachelor’s Degree in a science or Engineering discipline required
- 7+ years relevant experience in computer system validation (e.g., MES, SCADA, PI Factory Talk Historian, Building Management system (BMS, QBAS), Serialization, QC systems)
- Experience with ALM or Kneat testing tool is a plus
- Experience with ServiceNow (Problem, Change management), Trackwise (Change Management), Veeva (Document management, CAPA, Deviations, Change Management)
- Knowledge of cGMP regulations and guidelines including but not limited to U.S. code of Federal Regulations 21 CFR Part 11 and Part 211
- Understanding of industry standards and best practices for computer system validation such as GAMP 5
About SSi People:
With over 26 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering an exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.
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