Job Title
cGMP Computer System Validation Specialist
Job Type
Full-time
Category
Information Technology
Location
FAIRFAX - , VA 22030 US (Primary)
Education
Bachelor's Degree
Travel
0 - 10%
Job Description
You keep the Stockpile's systems in a validated state under cGMP and 21 CFR Part 11, from validation plans and IQ, OQ and PQ through change control and periodic review, so that electronic records and signatures stand up to inspection. Full time, W-2, based in Fairfax, Virginia with some telework, starting October 2026.
What you will do- Own computer system validation for the legacy and cloud systems: validation master plan, risk assessments, IQ, OQ and PQ protocols and reports, traceability matrices, periodic reviews.
- Assess every change and patch for validation impact; run or oversee revalidation; keep the validated state documented.
- Maintain 21 CFR Part 11 controls: electronic records, electronic signatures, audit trails, access.
- Write and maintain cGMP procedures and training for the team; support inspections and audits with evidence.
- Work with QA, the release manager and the DBAs so validation is part of the release path, not an afterthought.
What you need- 5 or more years of computer system validation in a cGMP or otherwise FDA-regulated environment, with hands-on IQ, OQ and PQ.
- Working knowledge of 21 CFR Part 11, GAMP 5 and risk-based validation.
- Experience validating an ERP or inventory system.
- Precise technical writing.
- U.S. citizenship and the ability to obtain an HHS Tier 2 public trust determination.
What sets a candidate apart- Oracle E-Business Suite validation.
- Pharmaceutical or medical device supply chain.
- Cloud-hosted validated systems.
- ASQ or ISPE credentials.
BenefitsPay is discussed with you directly when we speak. These are the benefits every full-time SPN employee receives.
- Medical and prescription coverage, dental and vision, with employer-subsidized premiums for employees and dependents
- 401(k) with employer match
- Group life insurance at no cost to you
- Short-term and long-term disability
- Paid time off, 11 federal holidays, paid sick leave, bereavement leave
- Parental leave
- Certification reimbursement (Oracle, OCI, AWS/Azure, PMP, ITIL, Security+, CISSP and others), an annual training budget and tuition assistance
Terms, and how to apply- Full time, W-2, salaried (exempt), employed by SPN Solutions
- Target start: October 2026
- Hybrid: based at SPN's office in Fairfax, Virginia, with some telework; occasional days at the customer's Atlanta, Georgia campus when the work requires it
- Core hours 9:00 a.m. to 3:30 p.m. Eastern, Monday to Friday, with flexible start between 6:00 and 9:00 a.m. Eastern; federal holidays off
- You must be a U.S. citizen and obtain and keep an HHS Tier 2 (moderate risk) public trust determination; no security clearance is required
- You complete HHS security, privacy and records management training before access, and cGMP training shortly after you start
- Work is done on customer-furnished or SPN-furnished equipment under HHS security rules
Apply through the link with your resume; it takes a few minutes and no cover letter is needed. A recruiter reads every application and answers within two business days. The process is short: one conversation with a recruiter, one technical conversation with the team, then a decision.
Keywords: cGMP Validation Specialist, computer system validation, CSV, 21 CFR Part 11, GAMP 5, IQ OQ PQ, validation master plan, change control, electronic records, electronic signatures, Oracle EBS validation, pharmaceutical, public trust, Fairfax VA, Northern Virginia, hybrid
