About this role
<div id="jobreq_print_container"> <p><span style="font-family:arial, helvetica, sans-serif"><strong>Join Us in Changing Lives</strong></span></p> <p> </p> <p><span style="font-family:arial, helvetica, sans-serif"><strong>Full time, On-site</strong></span></p> <p> </p> <p><span style="font-family:arial, helvetica, sans-serif">At <strong>OXB</strong>, 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: <strong>Responsible, Responsive, Resilient, and Respectful</strong>.</span></p> <p> </p> <p><span style="font-family:arial, helvetica, sans-serif">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.</span></p> <p> </p> <p><span style="font-family:arial, helvetica, sans-serif">We are currently recruiting for a <strong>Validation Engineer III</strong> 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. You will play a key role in advancing our mission and making a meaningful difference.</span></p> <p> </p> <p><span style="font-family:arial, helvetica, sans-serif">This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the United States.</span></p> <p><span style="font-family:arial, helvetica, sans-serif"><strong>Your responsibilities in this role would be:</strong></span></p> <p> </p> <ul style="list-style-type:disc" type="disc"> <li style="font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Write, execute, summarize and lead validation activities for: Analytical instruments, Computer Systems (as applicable to complex instruments and manufacturing equipment),Equipment, Utilities, and Facilities.</span></li> <li style="font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Development of Validation Plans and Validation Plan Summary Reports.</span></li> <li style="font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Develop, review, and provide guidance on internal validation documents.</span></li> <li style="font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Develop, support, and assess CAPAs, Change Controls, Deviations, Investigations and Risk Management as they pertain to validation.</span></li> <li style="font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Provide technical input to strategy/philosophy for validation activities.</span></li> <li style="font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Represent validation during tech transfer activities.</span></li> <li style="font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Front facing during agency inspections client audits representing the validation function.</span></li> <li style="font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Lead and manage complex validation and technical projects.</span></li> <li style="font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Provide technical support for troubleshooting, improving, or optimizing ongoing manufacturing operations, including being on-call for after-hours remote support.</span></li> </ul> <p> </p> <p><span style="font-family:arial, helvetica, sans-serif"><strong>We are Looking For:</strong></span></p> <ul style="list-style-type:disc" type="disc"> <li style="font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Minimum of bachelor’s degree in science, engineering or related discipline.</span></li> <li style="font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">5+ years of experience in the execution of validation studies in a regulated manufacturing environment.</span></li> <li style="font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Thorough knowledge and understanding of FDA and international health authority expectations.</span></li> <li style="font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">Experience in authoring and review/approval of CQV documentation including validation plans, protocols, reports, trace matrices and SOPs</span></li> </ul> <p><span style="font-family:arial, helvetica, sans-serif"><strong> </strong></span></p> <p><span style="font-family:arial, helvetica, sans-serif"><strong>About Us:</strong></span></p> <p><span style="font-family:arial, helvetica, sans-serif">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; the driving force behind the majority of gene therapies.</span></p> <p><span style="font-family:arial, helvetica, sans-serif">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. OXB’s world-class capabilities span from early-stage development to commercialisation. These capabilities are supported by robust quality-assurance systems, analytical methods, and depth of regulatory expertise.</span></p> <p><span style="font-family:arial, helvetica, sans-serif"><strong> </strong></span></p> <p><span style="font-family:arial, helvetica, sans-serif"><strong>Why Join Us?</strong></span></p> <ul style="list-style-type:disc" type="disc"> <li style="font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">💸 Competitive total reward packages</span></li> <li style="font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">🧘 Wellbeing programs that support your mental and physical health</span></li> <li style="font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">🚀 Career development opportunities to help you grow and thrive</span></li> <li style="font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">🤝 Supportive, inclusive, and collaborative culture</span></li> <li style="font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">🧪 State-of-the-art labs and manufacturing facilities</span></li> <li style="font-family:arial, helvetica, sans-serif"><span style="font-family:arial, helvetica, sans-serif">🌍 A company that lives its values: <strong>Responsible, Responsive, Resilient, Respect</strong></span></li> </ul> <p> </p> <p><span style="font-family:arial, helvetica, sans-serif">We want you to feel inspired every day. At OXB, we’re future-focused and growing fast. We succeed together—through passion, commitment, and teamwork.</span></p> <p> </p> <p> </p> <p><span style="font-family:arial, helvetica, sans-serif"><strong>Ready to Make a Difference?</strong></span></p> </div>