CSV Lead

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

Position

CSV Lead

Location

Durham, NC (Hybrid, must visit site 2-3 days a week)

Duration

1 Year

Job Description

Must have worked in CSV in Manufacturing automation systems like DELTA V,PI Historian, PLC, LAB Automation Systems(any one pf the systems or all).

Primary

CSV (Computer System Validation) Compliance

Secondary

SDLC / CSA / Validation Governance / Quality Compliance.

Hands-on experience supporting validation and compliance activities for computerized manufacturing systems in a regulated pharmaceutical environment.

Familiar with Kneat,SNOW,Veeva Systems.

Provide CSV compliance support for Capital and Strategic Projects to ensure continuity of compliance oversight and project delivery.

Develop, review, and approve validation lifecycle deliverables in accordance with GxP requirements, internal SOPs, and regulatory expectations.

Provide compliance guidance to project teams on SDLC, CSA (Computer Software Assurance), qualification, risk-based validation, and change control processes. Strong experience in Computer System Validation (CSV) within GMP-regulated pharmaceutical/manufacturing environments. Knowledge of Validation Lifecycle, CSA, SDLC, Qualification (IQ/OQ/PQ), Change Control, CAPA, and Risk Management.

Experience reviewing and approving validation documentation and compliance deliverables.

Familiarity with GxP regulations, Data Integrity, FDA, EMA, and industry compliance requirements.

Exposure To One Or More Manufacturing Automation Platforms Including

• DeltaV DCS
• PLC systems (Rockwell and/or Siemens)
• Process Historians
• Laboratory Automation Systems Experience with validation, qualification, change control, risk assessments, and lifecycle compliance activities associated with manufacturing and laboratory computerized systems.
• Understanding of GxP, Data Integrity, CSV/CSA, and SDLC requirements for manufacturing automation platforms.