Join Us in Changing Lives 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. We’re currently recruiting for a Principal Validation Specialist to join our Validation team. In this role you will lead the CSV Validation team which makes up part of the wider validation team who execute validation activities to generate validation deliverables for high value, high criticality/complexity validation projects in accordance with agreed timelines and all applicable regulatory standards and guidelines. Your responsibilities in this role would be: • Leads and manages a group of CSV validation specialists. Prioritise and resources workload efficiently. • Leads, supports and is a SME for computer systems quality implementation, migration, and validation activities following risk-based approach. • Maintains and manages system lifecycle documentation (URS, DQ, IQ/OQ/PQ, VR, SOPs, etc.). Ensures systems remain audit-ready and compliant with GMP, and CSV requirements • Guides and supports business system owners with system/equipment URS and uses their subject matter expertise for systems risk assessments. • Ensures systems data integrity compliance across the business is maintained • Promotes and aligns continuous improvement initiatives. We are looking for: • BSc (or higher) in a relevant scientific or engineering discipline • Extensive knowledge of the current standards and regulations and guidelines as they relate to qualification/validation of computer systems. • Extensive and widely gained experience and subject matter expertise in the qualification, requalification & validation of computerised systems within a pharmaceuticals/biologics GMP environment • Demonstrates practicality of risk-based validation approach. • Previous experience managing teams and people. • The proven ability to work in multi-project environments, identify priorities and work collaboratively, utilising effective time management skills. • Previous experience with Agile projects environment preferred. • Relevant industry training & qualifications advantageous (e.g. ISPE / GAMP, ISTQB) • Excellent spoken & written English communication and proven influencing skills at varying levels within the organisation, across functions and multiple project teams. 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 25 years of experience in viral vectors; the driving force behind the majority of gene therapies. 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. Why Join Us? • Competitive total reward packages • Wellbeing programmes 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: Responsible, Responsive, Resilient, Respect 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. Ready to Make a Difference? Collaborate. Contribute. Change lives. We are looking for: • BSc (or higher) in a relevant scientific or engineering discipline • Extensive knowledge of the current standards and regulations and guidelines as they relate to qualification/validation of computer systems. • Extensive and widely gained experience and subject matter expertise in the qualification, requalification & validation of computerised systems within a pharmaceuticals/biologics GMP environment • Demonstrates practicality of risk-based validation approach. • Previous experience managing teams and people. • The proven ability to work in multi-project environments, identify priorities and work collaboratively, utilising effective time management skills. • Previous experience with Agile projects environment preferred. • Relevant industry training & qualifications advantageous (e.g. ISPE / GAMP, ISTQB) • Excellent spoken & written English communication and proven influencing skills at varying levels within the organisation, across functions and multiple project teams. 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 25 years of experience in viral vectors; the driving force behind the majority of gene therapies. 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. Why Join Us? • Competitive total reward packages • Wellbeing programmes 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: Responsible, Responsive, Resilient, Respect 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. Ready to Make a Difference? Collaborate. Contribute. Change lives Oxford Biomedica is a quality and innovation-led viral vector CDMO that enables its clients to deliver life-changing therapies to patients around the world. One of the original pioneers in cell and gene therapy, Oxford Biomedica has more than 25 years of experience in viral vectors, the driving force behind the majority of gene therapies. Cell and gene therapy is the treatment of disease by the delivery of therapeutic genetic material (DNA or RNA), into a patient’s cells. One highly effective approach to delivering genetic information is to re-engineer existing viruses to be safe delivery vehicles (vectors) to insert the genetic material into patients’ cells. This can be achieved either by directly administering the vector to the patient (often referred to as in vivo gene therapy), or by first introducing the genetic material to cells or tissue outside of the body, before administering the cells or tissue into the patient (often referred to as ex vivo gene therapy or gene-modified cell therapy). Oxford Biomedica 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. Oxford Biomedica'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. Oxford Biomedica is a quality and innovation-led viral vector CDMO that enables its clients to deliver life-changing therapies to patients around the world. One of the original pioneers in cell and gene therapy, Oxford Biomedica has more than 25 years of experience in viral vectors, the driving force behind the majority of gene therapies. Cell and gene therapy is the treatment of disease by the delivery of therapeutic genetic material (DNA or RNA), into a patient’s cells. One highly effective approach to delivering genetic information is to re-engineer existing viruses to be safe delivery vehicles (vectors) to insert the genetic material into patients’ cells. This can be achieved either by directly administering the vector to the patient (often referred to as in vivo gene therapy), or by first introducing the genetic material to cells or tissue outside of the body, before administering the cells or tissue into the patient (often referred to as ex vivo gene therapy or gene-modified cell therapy). Oxford Biomedica 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. Oxford Biomedica'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.