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- Tasks: Join our Validation Department to ensure compliance and support major customer projects.
- Company: Oxford Biomedica is a leader in cell and gene therapy, transforming lives with innovative solutions.
- Benefits: Enjoy competitive rewards, wellbeing programs, and development opportunities in a supportive environment.
- Why this job: Be part of a future-focused team driving innovation and making a real impact on patients' lives.
- Qualifications: A degree in Science or Engineering, with experience in GMP regulations and validation processes.
- Other info: Work in state-of-the-art facilities and collaborate with top pharmaceutical and biotech companies.
The predicted salary is between 36000 - 60000 £ per year.
We are at the centre of the rapidly growing cell and gene therapy sector. We deliver life-changing therapies to patients, and so can you.
About the Role
We are currently recruiting for a Validation Specialist to join the Validation Department. This team is responsible for generating, executing, and reporting on validation activities related to GMP systems, including equipment, facilities, and utilities. This is an exciting opportunity to work on high-value projects with cross-functional teams, supporting the delivery of major customer projects, ensuring regulatory compliance, and contributing to the company's growth.
Your Responsibilities
- Preparation and execution of validation lifecycle documents (URS, DQ, IQ, OQ & PQ) and reporting.
- Participating in cross-functional meetings to provide validation support to internal SMEs.
- Owning quality records such as Deviations, Change Controls, and CAPAs for the Validation Department.
- Supporting validation activities during new manufacturing processes, including equipment, facilities, and utilities qualification.
- Maintaining department KPIs and routine validation activities for equipment, facilities, utilities, processes, and computerised systems.
Candidate Profile
We are looking for:
- A Degree (or equivalent) in Science, Engineering, or a related discipline.
- Knowledge of current standards, GMP regulations, and industry guidelines related to qualification/validation.
- Experience in validating equipment, utilities, and facilities.
- Experience in authoring, reviewing, and executing validation documents (URS, DQ, IQ, OQ & PQ).
- Experience working within a GMP Quality Management System.
- Highly organised with strong problem-solving skills, thoroughness, and teamwork.
- Effective oral, written, and interpersonal communication skills.
- Ability to adapt to rapid project changes and meet deadlines.
- Desirable: Experience with cleaning validation and generation/execution of validation documents.
About Us
Oxford Biomedica is a pioneering viral vector CDMO committed to enabling life-changing therapies. With over 25 years of experience, we collaborate with leading pharmaceutical and biotech companies, providing expertise from development to commercialization, supported by robust quality and regulatory systems.
What We Offer
- Competitive rewards
- Wellbeing programs
- Development opportunities
- Supportive colleagues and inclusive environment
- State-of-the-art facilities
Join us to be part of a future-focused, rapidly growing business where passion, teamwork, and innovation drive success. Collaborate. Contribute. Change lives.
Validation Specialist, Equipment, Facilities & Utilities. employer: OXB
Contact Detail:
OXB Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Validation Specialist, Equipment, Facilities & Utilities.
✨Tip Number 1
Familiarise yourself with the latest GMP regulations and industry guidelines. This knowledge will not only help you in interviews but also demonstrate your commitment to compliance and quality, which is crucial for a Validation Specialist.
✨Tip Number 2
Network with professionals in the cell and gene therapy sector. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends, which can give you an edge during discussions.
✨Tip Number 3
Prepare to discuss specific validation projects you've worked on. Be ready to explain your role, the challenges faced, and how you contributed to successful outcomes, as this will showcase your hands-on experience.
✨Tip Number 4
Demonstrate your problem-solving skills by preparing examples of how you've tackled issues in past roles. Highlighting your ability to adapt to rapid project changes will resonate well with the team at Oxford Biomedica.
We think you need these skills to ace Validation Specialist, Equipment, Facilities & Utilities.
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in validation, GMP regulations, and any specific projects you've worked on that relate to equipment, facilities, and utilities. Use keywords from the job description to catch the employer's attention.
Craft a Strong Cover Letter: In your cover letter, express your passion for the cell and gene therapy sector and how your skills align with the responsibilities of the Validation Specialist role. Mention specific experiences that demonstrate your problem-solving abilities and teamwork.
Highlight Relevant Qualifications: Clearly state your degree and any additional qualifications related to science or engineering. Emphasise your knowledge of current standards and industry guidelines, as well as your experience in authoring validation documents.
Showcase Communication Skills: Since effective communication is key for this role, provide examples in your application of how you've successfully communicated complex information in previous roles, especially in cross-functional teams or during validation activities.
How to prepare for a job interview at OXB
✨Know Your Validation Documents
Familiarise yourself with the key validation lifecycle documents such as URS, DQ, IQ, OQ, and PQ. Be prepared to discuss your experience in authoring, reviewing, and executing these documents, as they are crucial for the role.
✨Understand GMP Regulations
Brush up on current GMP regulations and industry guidelines related to qualification and validation. Showing a solid understanding of these standards will demonstrate your commitment to compliance and quality.
✨Highlight Cross-Functional Collaboration
Prepare examples of how you've successfully worked with cross-functional teams in the past. This role requires collaboration with internal SMEs, so showcasing your teamwork skills will be beneficial.
✨Demonstrate Problem-Solving Skills
Be ready to discuss specific challenges you've faced in validation processes and how you resolved them. Highlighting your problem-solving abilities will show that you can adapt to rapid project changes and meet deadlines effectively.
