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# QA Validation Engineer

- **Company:** Technical Source
- **Location:** Raleigh, NC, United States
- **Experience:** Expert
- **Salary:** $100,000.0 - $130,000.0
- **Contract:** Permanent contract
- **Skills:** Business Process Modeling, Failure Mode Effects Analysis, Iq/oq/pq, GXP
- **Published:** May 19, 2026
- **Apply:** https://www.indeed.com/viewjob?jk=942d33d3f91bc606

## About the Role

+ ~5+ years in Quality Engineering, Validation, or a similar technical Quality role in a biotech/biopharma cGMP environment, + Strong understanding of cGMP and validation lifecycle concepts
 + Familiarity with GAMP 5 and computerized system expectations
 + Hands-on exposure to equipment and/or facility qualification, change control, deviations, and CAPA
 * Collaboration skills:
*

 + Comfortable working cross-functionally and communicating with Engineering, Manufacturing, and QA at all levels

Preferred Extras

 * Background in gene therapy, cell therapy, viral vectors, biologics, or sterile/aseptic manufacturing
 * Experience supporting new site startup, facility expansion, or tech transfer projects
 * Prior work in a fast-paced, small or mid-size biotech environment, * Full-time role, primarily standard business hours with some flexibility based on project and qualification activities

## Description

* Serve as a key Quality point of contact for facilities, utilities, and production/support equipment
 * Collaborate with Engineering, Manufacturing, and QA Ops on day-to-day and project work
 * Review and approve IQ/OQ/PQ protocols and reports for manufacturing and analytical equipment (including software/computerized systems)
 * Ensure qualification activities comply with cGMP, GAMP 5, and internal standards
 * Provide QA input into technology transfer and PPQ activities as processes move into or scale within the site
 * Verify that new or modified processes are appropriately assessed, validated, and documented
 * Lead or support deviations related to equipment, facilities, and engineering events
 * Perform or oversee root cause analysis and define practical, effective CAPAs
 * Draft and revise SOPs, technical work instructions, and validation/engineering documentation
 * Help streamline processes and close gaps as the site matures
 * Participate in or facilitate risk assessments (e.g., FMEA) for new equipment, changes, and processes
 * Recommend controls to reduce impact to product quality and patient safety


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