What are the responsibilities and job description for the IT Validation Lead – CSV position at Spadtek Solutions LLC?
Job Summary:
Looking for an experienced IT Validation Lead with strong CSV/CSA and GxP compliance background to support audit readiness and lead validation activities for IT systems in a life sciences environment.
Key Responsibilities:
- Lead Computer System Validation (CSV) activities across IT systems
- Support audit readiness and act as point of contact for audits
- Prepare and review validation documents (IQ/OQ/PQ, risk assessments)
- Ensure compliance with GxP, GAMP 5, FDA regulations
- Manage validation deliverables and timelines
- Collaborate with IT, Quality, and business teams
Required Skills:
- 8–10 years in CSV/CSA, IT validation, GxP compliance
- Strong experience in audit support and validation lifecycle
- Hands-on with validation documentation and frameworks
- Experience with application validation
Preferred:
- Veeva Vault experience
- Exposure to Quality Systems / Pharmacovigilance (PV)
Key Skills:
CSV | CSA | GxP | Validation | IQ/OQ/PQ | Audit | GAMP 5 | Veeva