CSV & Data Integrity Lead for GxP Systems

Scientific Protein Laboratories LLC; Waunakee (WI); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Medical, Dental and Vision on Day 1

401k with company match

Paid time off

Job summary

Scientific Protein Laboratories LLC in Waunakee, Wisconsin, is seeking a CSV & DI Compliance Manager to own the site program and ensure GxP systems are validated and compliant. You will lead IT and OT validation efforts, direct automation validation, and partner with QA Validation for final approval.

Role requires coordinating with QA Validation, Quality, IT, and Engineering to address data integrity risks and inspection readiness.

Qualifications

• Bachelor’s degree in engineering, computer science, life sciences, or related field.
• 8+ years of CSV and data integrity for GMP systems across IT and laboratory.
• 3+ years supporting FDA or equivalent inspections, including CAPA remediation.

Responsibilities

• Own the CSV and data integrity program for all GxP systems.
• Direct CSV/DI work by IT and OT teams, including validation of PLCs, HMIs, SCADA.
• Lead remediation, CAPA actions, and regulatory inspection responses.

Skills

CSV knowledge

Data integrity

GxP systems

Regulatory inspections

Education

Bachelor's degree

Job description

Scientific Protein Laboratories LLC in Waunakee, Wisconsin, is seeking a CSV & DI Compliance Manager to own the site program and ensure GxP systems are validated and compliant. You will lead IT and OT validation efforts, direct automation validation, and partner with QA Validation for final approval.

Role requires coordinating with QA Validation, Quality, IT, and Engineering to address data integrity risks and inspection readiness.