OXB · 9 hours ago
Validation Engineer III
Durham, NC
Full-time
Onsite
Senior Level
5+ years expOXB is a quality and innovation-led viral vector CDMO with a mission to enable its clients to deliver life changing therapies to patients around the world. In this role, you will support Engineering, Manufacturing, Quality Control, and Facilities teams by executing validation and qualification of equipment, utilities, facilities, and systems, playing a key role in advancing the company's mission.
BiotechnologyGeneticsTherapeutics
No H1B
Responsibilities
Write, execute, summarize and lead validation activities for: Analytical instruments, Computer Systems (as applicable to complex instruments and manufacturing equipment), Equipment, Utilities, and Facilities
Development of Validation Plans and Validation Plan Summary Reports
Develop, review, and provide guidance on internal validation documents
Develop, support, and assess CAPAs, Change Controls, Deviations, Investigations and Risk Management as they pertain to validation
Provide technical input to strategy/philosophy for validation activities
Represent validation during tech transfer activities
Front facing during agency inspections client audits representing the validation function
Lead and manage complex validation and technical projects
Provide technical support for troubleshooting, improving, or optimizing ongoing manufacturing operations, including being on-call for after-hours remote support
Qualification
Required
Minimum of bachelor's degree in science, engineering or related discipline
5+ years of experience in the execution of validation studies in a regulated manufacturing environment
Thorough knowledge and understanding of FDA and international health authority expectations
Experience in authoring and review/approval of CQV documentation including validation plans, protocols, reports, trace matrices and SOPs
Benefits
Competitive total reward packages
Wellbeing programs that support your mental and physical health
Career development opportunities to help you grow and thrive
Supportive, inclusive, and collaborative culture
State-of-the-art labs and manufacturing facilities
Company
OXB
OXB (LSE: OXB) is a global quality and innovation-led contract development and manufacturing organisation (CDMO) in cell and gene therapy with a mission to enable its clients to deliver life changing therapies to patients around the world.
501-1000 employees
Funding
Current Stage
Public CompanyTotal Funding
$217.05MKey Investors
Oaktree Capital ManagementSerum Institute of India Pvt. Ltd.
2025-08-01Post Ipo Debt· $60M
2021-09-22Post Ipo Equity· $68.08M
2019-05-01Post Ipo Equity· $69.83M
Leadership Team
Emily Yu
Oxford BioMedica CMO
Recent News
2026-01-16
2026-01-16
2026-01-16
Company data provided by crunchbase