GxP CSV & Data Integrity Manager

Scientific Protein Laboratories LLC

United States

On-site

USD 120,000 - 180,000

Full time

12 days ago

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Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

AD&D

Disability Insurance

401k

Vacation

Employee Assistance Program

Flexible Spending Account

Company events

Job summary

Scientific Protein Laboratories LLC (SPL) near Madison, Wisconsin, seeks a CSV & DI Compliance Manager to establish and sustain the CSV/DI program for GxP computerized systems across IT, QA, and Engineering. Lead the CSV Engineer and coordinate with automation teams and QA Validation to ensure compliant, audit-ready systems.

You will manage risk-based planning, remediation efforts, and regulatory inspections, while partnering with QA Validation to maintain SPL standards and policies across the

Qualifications

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

Responsibilities

Own and govern the CSV and data integrity program for all GxP systems.
Direct CSV and data integrity work by IT and OT teams, including validation
Lead inspections and responses, ensuring defensible systems and compliance.

Skills

CSV & Data Integrity

Regulatory Inspections

Leadership

Education

Bachelor's degree in engineering / related technical field

Tools

PLC

HMI

SCADA

Job description

You will manage risk-based planning, remediation efforts, and regulatory inspections, while partnering with QA Validation to maintain SPL standards and policies across the

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