CSV Compliance Lead - Hybrid Manufacturing (Durham)

Inherent Technologies, Inc.; Durham (NC); Hybrid; USD 90,000 - 125,000; Full time

Job summary

Inherent Technologies, Inc. is seeking a CSV Lead in Durham, NC for a 1-year hybrid role. You will support validation of manufacturing automation systems and ensure CSV/CSA governance, data integrity, and regulatory compliance across projects.

You will work with DELTA V DCS, PLCs, process historians, and laboratory automation platforms, providing expert guidance and delivering compliant validation deliverables per GMP requirements.

Qualifications

• Must have CSV experience in manufacturing automation systems (e.g., DELTA V, PLC, LAB automation).
• Experience validating and supporting CRO/Pharma projects under GxP.
• Familiarity with CSA, SDLC, qualification (IQ/OQ/PQ), Change Control and CAPA.
• Knowledge of FDA/EMA regulatory expectations and data integrity principles.
• Ability to review and approve validation documents and deliverables.

Responsibilities

• Provide CSV compliance oversight for Capital and Strategic Projects to ensure compliant delivery.
• Develop, review, and approve validation lifecycle deliverables per GxP and SOPs.
• Offer guidance on SDLC/CSA, qualification, risk-based validation, and change control.
• Support validation activities across manufacturing and laboratory computerized systems.

Skills

CSV Validation

GxP Compliance

SDLC/CSA

Data Integrity

Quality Compliance

Regulatory Compliance

Kneat

SNOW

Veeva Systems

DeltaV DCS

PLC Systems

Process Historians

Laboratory Automation

CAPA

Risk Management

Tools

Kneat

SNOW

Veeva Systems

DeltaV DCS

PLC (Rockwell/Siemens)

Process Historians

Job description

Inherent Technologies, Inc. is seeking a CSV Lead in Durham, NC for a 1-year hybrid role. You will support validation of manufacturing automation systems and ensure CSV/CSA governance, data integrity, and regulatory compliance across projects.

You will work with DELTA V DCS, PLCs, process historians, and laboratory automation platforms, providing expert guidance and delivering compliant validation deliverables per GMP requirements.