Principal Validation Specialist, CSV

OXB; Oxford; On-site; GBP 65,000 - 85,000; Full time

Job summary

A leading biopharmaceutical company in Oxford is seeking a Principal Validation Specialist to lead the CSV Validation team. This role involves managing validation activities to ensure compliance with regulatory standards. Ideal candidates will have extensive experience in the qualification and validation of computerized systems, along with strong team management skills. The company offers competitive rewards and a collaborative work environment.

Benefits

Competitive total reward packages

Wellbeing programmes

Career development opportunities

Supportive and inclusive culture

State-of-the-art labs and facilities

Qualifications

• Extensive knowledge of standards and regulations for computer systems qualification.
• Experience in qualification and validation in pharmaceuticals/biologics GMP environment.
• Ability to work in multi-project environments.

Responsibilities

• Lead and manage a group of CSV validation specialists.
• Ensure systems remain audit-ready and compliant with GMP requirements.
• Promote continuous improvement initiatives.

Skills

Team management

Risk-based validation

Regulatory knowledge

Excellent communication

Project management

Education

BSc (or higher) in a relevant scientific or engineering discipline

Job description

Overview

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.

Responsibilities

• Leads and manages a group of CSV validation specialists. Prioritise and resource 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.

Qualifications

• 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 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.
• 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.