Validation Engineer (W2 Contract)

Title: Validation Engineer

Location: New Albany, OH (Onsite)

Duration: 6+ months initial contract with extension

*****This is W2 Contract Only******

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 (Client, QBAS), Serialization, QC systems).

Technical / Knowledge:

1. Experience with ALM or Kneat testing tool is plus.

2. Experience with ServiceNow, Track wise (CAPA, Deviations), 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.

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.*Must have experience with deviations

*IT infrastructure tools is highly preferred but not required (example: backup and restore, disaster recovery)

Day to Day Responsibilities:

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.

Thanks

Dimpul Kumar

+1 650-618-3908

dimpulk@aditiconsulting.com