System Validation Engineer

Note: Open to the candidates who are either USC / GC / EAD a big no to C2C.

Job Title: Validation Engineer - Onsite

Location: New Albany, OH

Pay Rate: $39/hr to $42/hr

Responsibilities:

• Perform Deviations, CAPA, Change records for DTI computer systems (E.g: MES, SCADA, ASRS, ServiceNow, QBAS, SAP/ERP, Serialization, etc).
• Provide support to system owners on completing Design Spec, URS, Traceability, IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification) draft copies.
• Provide support on completion of 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.
• Ensures that systems are maintained in a compliant manner according to the DTI quality systems standards.
• Support regulatory inspections and internal audits as required.

Required Skills:

• Experience with testing tools (ALM, or Kneat or ValGenesis).
• Experience with ServiceNow (Change Module), Track wise (CAPA, Deviations, Change), 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.

With over 20 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.