Senior Validation Engineer I

Forge Biologics(11 days ago)

Columbus, OhioOnsiteFull TimeSenior$114,549 - $155,342 (estimated)Quality

About this role

Senior Validation Engineer I at Forge Biologics will lead design and execution of process validation and aseptic process simulation activities to ensure compliant, high-quality AAV and cell/gene therapy manufacturing. The role partners with cross-functional teams to develop validation strategies, perform hands-on qualification work, and drive continuous improvement in a cGMP facility. It supports commissioning/qualification of equipment, mentoring of junior staff, and staying current with regulatory expectations.

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Required Skills

Process Validation
Aseptic Processing
Media Fill
Equipment Qualification
cGMP
Risk Assessment
Statistical Analysis
Project Management
Protocol Generation
Data Analysis

+3 more

Qualifications

Bachelor's Degree in Engineering, Biotechnology, or Pharmaceutical Sciences

About Forge Biologics

forgebiologics.com

Forge Biologics is a CDMO focused on accelerating gene therapy manufacturing, specializing in high‑yield adeno‑associated virus (AAV) vector production. The company offers end‑to‑end services including process and analytical development, clinical‑to‑commercial cGMP manufacturing at a world‑class facility, and regulatory and supply‑chain support. Clients partner with Forge for scalable AAV capacity, technical expertise, and seamless program support to move therapies faster toward patients.