cGMP CSV Specialist — Hybrid (Oracle Cloud)

HRsmart; Fairfax (VA); Hybrid; USD 120,000 - 150,000; Full time

Benefits offered by this job

Medical and prescription coverage

Dental and vision insurance

401(k) with employer match

Group life insurance

Short-term and long-term disability

Paid time off and federal holidays

Job summary

SPN Solutions in Fairfax, VA is seeking a cGMP Computer System Validation Specialist to maintain validated state for ERP systems and cloud migrations under 21 CFR Part 11.

You will lead validation plans, IQ/OQ/PQ, assess changes, support inspections, and collaborate with QA, DBAs, and release teams. Requires 5+ years of CSV in FDA-regulated environments, precise writing, US citizenship, and the ability to obtain HHS Tier 2 public trust.

Qualifications

• 5+ years of computer system validation in a cGMP or FDA-regulated environment.
• Experience with IQ, OQ, PQ and validation documentation.
• Working knowledge of 21 CFR Part 11 and GAMP 5.
• Experience validating an ERP/inventory system.
• Precise technical writing.
• U.S. citizenship and ability to obtain HHS Tier 2 public trust.

Responsibilities

• Own cGMP computer system validation for legacy and cloud systems.
• Assess changes for validation impact and perform revalidation.
• Maintain 21 CFR Part 11 controls and audit trails.
• Write and maintain cGMP procedures and training.
• Support inspections and audits with evidence.

Skills

Technical writing

Regulatory compliance

cGMP knowledge

FDA-regulated environments

Education

Bachelor's Degree

Tools

Oracle E-Business Suite

ERP systems

Job description

SPN Solutions in Fairfax, VA is seeking a cGMP Computer System Validation Specialist to maintain validated state for ERP systems and cloud migrations under 21 CFR Part 11.

You will lead validation plans, IQ/OQ/PQ, assess changes, support inspections, and collaborate with QA, DBAs, and release teams. Requires 5+ years of CSV in FDA-regulated environments, precise writing, US citizenship, and the ability to obtain HHS Tier 2 public trust.