CSV Lead - Hybrid, Pharma Validation & Compliance

Raas Infotek LTD; Durham, Northern (NC, KY); Hybrid; USD 120,000 - 180,000; Full time

Job summary

Raas Infotek LTD is seeking a CSV Lead for a hybrid role in Durham, NC. The candidate will ensure CSV compliance for manufacturing automation systems and support validation activities in a regulated environment.

Responsibilities include reviewing validation deliverables, providing guidance on SDLC/CSA, and working with platforms such as DeltaV, PLCs, Process Historians, and Lab Automation Systems. W2 only.

Qualifications

• Experience in CSV within GMP-regulated pharmaceutical/manufacturing environments.
• Familiar with GxP, Data Integrity, FDA/EMA requirements.
• Experience with validation lifecycle deliverables (IQ/OQ/PQ) and change control.
• Exposure to manufacturing automation platforms (DeltaV DCS, PLCs, Process Historians).

Skills

CSV validation

GxP compliance

SDLC/CSA

Regulatory guidance

Tools

DeltaV

PI Historian

Kneat

Veeva Systems

Job description

Raas Infotek LTD is seeking a CSV Lead for a hybrid role in Durham, NC. The candidate will ensure CSV compliance for manufacturing automation systems and support validation activities in a regulated environment.

Responsibilities include reviewing validation deliverables, providing guidance on SDLC/CSA, and working with platforms such as DeltaV, PLCs, Process Historians, and Lab Automation Systems. W2 only.