Senior CSV Lead: Regulated Systems Validation Expert

Katalyst CRO; Tulsa (OK); On-site; USD 120,000 - 160,000; Full time

Job summary

Katalyst CRO in Tulsa, OK is seeking an experienced CSV Lead to oversee validation activities for GxP computer systems. The role requires extensive CSV lifecycle management, strong FDA and global regulatory compliance, and the ability to develop validation documentation, risk assessments, and validation plans that meet business needs.

You will coordinate with IT, Quality Assurance, Engineering, and Manufacturing; mentor junior CSV engineers; and support internal and regulatory audits and

Qualifications

• 8–12+ years of CSV experience in pharma or life sciences.
• Strong knowledge of 21 CFR Part 11 and Annex 11.
• Experience with IQ/OQ/PQ validation activities.
• Ability to mentor junior CSV engineers.

Responsibilities

• Lead end-to-end CSV activities for GxP systems.
• Develop and review validation plans, protocols, and reports.
• Ensure compliance with global regulatory requirements.
• Coordinate with IT, QA, and Manufacturing teams.
• Support internal audits, customer audits, and regulatory inspections.
• Mentor junior CSV engineers and maintain lifecycle documentation.

Skills

CSV lifecycle management

FDA compliance

GxP validation

Cross-functional leadership

Education

Bachelor's or Master's degree in a related field

Tools

LIMS

MES

ERP (SAP)

SCADA

DMS

QMS

EBR

Job description

Katalyst CRO in Tulsa, OK is seeking an experienced CSV Lead to oversee validation activities for GxP computer systems. The role requires extensive CSV lifecycle management, strong FDA and global regulatory compliance, and the ability to develop validation documentation, risk assessments, and validation plans that meet business needs.

You will coordinate with IT, Quality Assurance, Engineering, and Manufacturing; mentor junior CSV engineers; and support internal and regulatory audits and