Senior CSV Lead: Regulated Systems Champion

Fives DyAG Corp.; Tulsa (OK); On-site; USD 110,000 - 160,000; Full time

Job summary

Fives DyAG Corp. is seeking an experienced Computer System Validation (CSV) Lead to oversee validation activities for GxP computer systems and ensure compliance with FDA and global requirements.

You will drive IQ/OQ/PQ execution, author validation plans and reports, mentor junior engineers, and coordinate with IT, QA, and manufacturing to maintain robust validation lifecycle documentation.

Qualifications

• 8–12+ years of CSV experience in pharma or life sciences.
• Strong knowledge of GxP regulations and 21 CFR Part 11.
• Experience with IQ, OQ, PQ validation activities.
• Experience with regulatory inspections and audits.

Responsibilities

• Lead end-to-end CSV activities for GxP systems.
• Develop and review validation plans, protocols, and reports.
• Execute IQ/OQ/PQ testing and documentation.
• Coordinate with IT, QA, Engineering, and Manufacturing.
• Mentor junior CSV engineers.

Skills

CSV lifecycle management

Regulatory compliance

Risk assessments

Cross-functional collaboration

Documentation practices

Education

Bachelor's degree in Computer Science / IT / Biotech / Pharmacy / Engineering

Tools

LIMS

MES

ERP (SAP)

SCADA

PLC/HMI

QMS

DMS

Job description

Fives DyAG Corp. is seeking an experienced Computer System Validation (CSV) Lead to oversee validation activities for GxP computer systems and ensure compliance with FDA and global requirements.

You will drive IQ/OQ/PQ execution, author validation plans and reports, mentor junior engineers, and coordinate with IT, QA, and manufacturing to maintain robust validation lifecycle documentation.