Quality Assurance Engineer (Contract)

> Encoded Therapeutics · Morrisville, United States · — · Posted 2026-05-19

Workplace: on_site

Department: Quality Assurance

Description

Encoded Therapeutics is a clinical-stage genetic medicines company developing precision gene therapies for pediatric central nervous system (CNS) disorders. As we expand our manufacturing and technical footprint in the vibrant Morrisville/RTP biotech corridor, we are seeking a mission-driven Quality Assurance Engineer (Contract) to help ensure our North Carolina operations meet the highest standards of safety, compliance, and excellence.

We are seeking a proactive and detail-oriented Quality Assurance Engineer to support our growing Morrisville operations. This role serves as a critical bridge between Engineering and Quality Assurance, providing technical oversight for equipment validation, facility management, and process performance. You will be instrumental in ensuring that our infrastructure and processes are robust, compliant, and ready to support the delivery of the next generation of genetic medicines.

Core Responsibilities

• Validation & Qualification (IQ/OQ/PQ): Lead the QA review and oversight of Installation, Operational, and Performance Qualifications for both manufacturing and analytical equipment (including computerized systems and software) within the Morrisville facility.
• Process Validation & Tech Transfer: Provide QA technical support for technology transfer activities and Process Performance Qualification (PPQ), ensuring the seamless integration of new processes into production.
• Facility & Engineering Oversight: Review and approve facility-related documentation, including work orders, asset management records, and engineering change controls to maintain site-wide compliance.
• Deviations & CAPA Management: Serve as the primary Quality contact for investigations and deviations related to facility and engineering issues; drive robust root-cause analysis and implement effective CAPAs.