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Validation Consultant
Job in
Rockford, Winnebago County, Illinois, 61103, USA
Listed on 2026-07-27
Listing for:
Shoolin Inc
Full Time
position Listed on 2026-07-27
Job specializations:
-
Quality Assurance - QA/QC
IT QA Tester / Automation -
IT/Tech
IT QA Tester / Automation
Job Description & How to Apply Below
We are seeking an experienced Validation Consultant with strong expertise in Databricks-based validation to support a critical project in a regulated environment. The ideal candidate will have hands‑on experience in validating data platforms, ensuring compliance with industry standards, and supporting validation lifecycle activities. This role requires a strong understanding of data integrity, computer system validation (CSV), and working knowledge of cloud-based data platforms such as Databricks.
Key Responsibilities:- Lead and execute validation activities for Databricks-based data platforms and pipelines
- Develop and review validation deliverables including Validation Plans, URS, FS, DS, IQ, OQ, and PQ documentation
- Ensure compliance with regulatory requirements such as FDA, GxP, and 21 CFR Part 11
- Perform risk assessments and define validation strategies for data workflows and systems
- Validate ETL processes, data transformations, and data integrity within Databricks environments
- Collaborate with cross-functional teams including IT, Data Engineering, Quality, and Compliance
- Support audit readiness and provide documentation during internal and external audits
- Identify gaps and recommend improvements to validation processes and data governance practices
- Ensure traceability between requirements, test cases, and validation deliverables
- Troubleshoot validation issues and support deviation investigations and CAPA activities
- Bachelor’s degree in Computer Science, Engineering, Life Sciences, or related field
- 5+ years of experience in Computer System Validation (CSV) or Data Validation in regulated industries
- Hands‑on experience with Databricks platform validation
- Strong understanding of GxP, FDA regulations, and 21 CFR Part 11 compliance
- Experience validating data pipelines, ETL processes, and cloud-based systems
- Knowledge of SDLC and validation lifecycle documentation
- Experience with data integrity principles (ALCOA+)
- Strong analytical, documentation, and problem‑solving skills
- Excellent communication and stakeholder management skills
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