CSV & Data Integrity Specialist

: We are seeking an experienced CSV & Data Integrity Specialist to support a client’s GMP remediation project in Madison, WI. This consultant will play a hands-on role in remediating identified Data Integrity gaps across GMP computerized systems, with a particular focus on Rockwell/Allen-Bradley PLC-based systems and associated automation environments. The consultant will work closely with the project and Quality teams to develop and update validation protocols, execute testing, document results, investigate discrepancies and deviations, and prepare validation deliverables and remediation evidence packages for Quality approval. Key areas of focus will include audit trails, electronic records, user access and security controls, data flows, backups and restoration, data retrieval, system administration, and data retention.

The ideal candidate will have approximately 4–7 years of experience in CSV, Data Integrity, automation, Quality, or a related GMP environment, with strong knowledge of 21 CFR Part 11, EU GMP Annex 11, ALCOA+, GAMP 5, and GDP-compliant validation practices. Strong hands-on experience with Rockwell Automation and Allen-Bradley PLCs is a huge plus and highly preferred, along with exposure to FactoryTalk, AssetCentre, iFIX, Active Directory, Veeam, or MasterControl. The consultant should be comfortable executing validation testing, reviewing audit trails and electronic records, verifying backup and recovery controls, investigating test discrepancies, and translating remediation requirements into clear, compliant validation documentation and procedures. This is a hands-on, onsite consulting opportunity for someone who can step into an active GMP remediation project and contribute immediately.