Validation Engineering

Validation Engineer III

Location: Durham, NC, US Company: oxfordbiom Join Us in Changing Lives Full time, On-site At OXB, our people are at the heart of everything we do. We're on a mission to enable life-changing therapies to reach patients around the world—and we're looking for passionate individuals who embody our core values every day: Responsible, Responsive, Resilient, and Respectful. Following the expansion of our US footprint with the acquisition of a new commercial-scale viral vector facility in Durham, North Carolina we have some new opportunities to join us. We are currently recruiting for a Validation Engineer III to join our Engineering Team. In this role, you will support Engineering, Manufacturing, Quality Control, and Facilities teams by executing initial validation and qualification of equipment, utilities, facilities, and systems, as well as implementing the requalification and periodic review program. Analytical instruments, Computer Systems (as applicable to complex instruments and manufacturing equipment), Equipment, Utilities, and Facilities.

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.

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.

We are Looking For: 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. About Us: OXB 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. One of the original pioneers in cell and gene therapy, we have more than 30 years of experience in viral vectors; OXB collaborates with some of the world's most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus (AAV) and adenoviral vectors. These capabilities are supported by robust quality-assurance systems, analytical methods, and depth of regulatory expertise.

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 A company that lives its values: