cGMP Computer System Validation Specialist

SPN Solutions Inc.; Fairfax (VA); Híbrido; USD 120.000 - 150.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical and prescription coverage

401(k) with employer match

Group life insurance

Disability insurance

Paid time off and holidays

Parental leave

Certification reimbursement

Descripción de la vacante

SPN Solutions seeks a cGMP Computer System Validation Specialist in Fairfax, VA to own validation for legacy and cloud systems, including IQ/OQ/PQ, change control and periodic reviews, ensuring FDA compliance.
Hybrid: on-site in Fairfax with some telework; requires US citizenship and readiness for Tier 2 public trust.

Formación

• 5+ years of computer system validation in cGMP or FDA-regulated environments.
• Knowledge of 21 CFR Part 11, GAMP 5, and risk-based validation.
• Experience validating ERP/inventory systems.
• Precise technical writing.
• US citizenship and ability to obtain HHS Tier 2 public trust.

Responsabilidades

• Own CSV for legacy and cloud systems: validation master plan, IQ/OQ/PQ, traceability, and periodic reviews.
• Assess changes for validation impact; oversee revalidation; maintain validated state.
• Maintain 21 CFR Part 11 controls: electronic records/signatures/audit trails.
• Write/maintain cGMP procedures; support inspections and audits with evidence.
• Collaborate with QA, release manager and DBAs to integrate validation into releases.

Conocimientos

CSV experience

cGMP knowledge

Part 11 knowledge

Technical writing

ERP validation

Educación

Bachelor's Degree

Herramientas

Oracle EBS

Oracle Cloud

Descripción del empleo

cGMP Computer System Validation Specialist - (155)

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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.

Why this job exists

SPN Solutions has won a new contract to operate and modernize the information systems behind the Strategic National Stockpile, part of HHS's Administration for Strategic Preparedness and Response (ASPR). The Stockpile holds the nation's reserve of medicines and medical supplies for public health emergencies. When a hurricane, an outbreak or another emergency calls for those supplies, the systems this team runs are how the country knows what it has, where it is and how fast it can move. The platform is Oracle E-Business Suite, and the program is moving it to Oracle Cloud while raising the quality of the inventory data and tightening the integration with the warehouse partners that hold the stock. You would join at the start, on a new team, with real work to own from the first week.

Why people take this job

• A mission you can explain at the dinner table: the nation's emergency medical supplies
• Hybrid in Fairfax, Virginia with some telework, sensible core hours and federal holidays off
• A modern Oracle stack and a real cloud migration, not a maintenance backwater
• A new team being built now: early hires shape how the work is done and grow with it
• Certifications and training paid for, with time set aside to earn them
• A company small enough that the people who run it know your name and answer your messages

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.

Pay 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.

SPN Solutions is an Equal Opportunity Employer. All qualified applicants are considered without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. SPN participates in E-Verify.

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