What are the responsibilities and job description for the CSV Lead Validation position at Scalable Systems?
CSV Lead – Validation
Location: Indianapolis, IN (Need Local only)
Job Summary:
The CSV Lead ensures compliance of computerized systems with FDA, GxP, and data integrity regulations. This role oversees validation activities, collaborates with cross-functional teams, and supports audits.
Key Responsibilities:
- Lead CSV activities for manufacturing, lab, and business systems.
- Develop and execute validation protocols (IQ, OQ, PQ).
- Ensure compliance with FDA 21 CFR Part 11, GAMP 5, and Data Integrity.
- Review validation deliverables and manage risk assessments.
- Support regulatory audits and train team members.
Qualifications:
- Bachelor’s/Master’s in Engineering, Computer Science, or Life Sciences.
- 5 years of CSV experience in pharma/biotech/medical devices.
- Expertise in LIMS, MES, ERP, and compliance frameworks.
- Strong documentation, problem-solving, and audit support skills.
