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For Companies At a Glance
- Tasks: Join us as a Validation Specialist, ensuring compliance in GMP systems and supporting high-value projects.
- Company: Oxford Biomedica is a pioneering CDMO in cell and gene therapy with over 25 years of experience.
- Benefits: Enjoy competitive rewards, a supportive team, and a diverse, inclusive work environment.
- Why this job: Be part of life-changing therapies and collaborate with innovative companies in a rapidly growing sector.
- Qualifications: A degree in Science/Engineering and experience in validation processes are essential.
- Other info: Work in state-of-the-art facilities and thrive in a culture of innovation and integrity.
The predicted salary is between 36000 - 60000 ÂŁ per year.
Position Overview
At OXB, our people are at the heart of everything we do. Weâre on a mission to enable lifeâchanging therapies to reach patients around the worldâand weâre looking for passionate individuals who embody our core values every day: Responsible, Responsive, Resilient, and Respectful.
Weâre currently recruiting for a Validation Specialist to join our Validation Equipment team. In this role, you will have the opportunity to participate in high value projects, working alongside crossâfunctional teams to deliver company goals, contribute to the delivery of major customer projects and the ensuring of regulatory compliance for GMP systems, playing a key part in advancing our mission and making a real difference.
Responsibilities
- Preparation and execution of validation deliverables for GMP systems.
- Providing SME support from Validation for project activities related to GMP systems.
- Active participation in crossâfunctional meetings and discussions to provide validation support to both internal and customer SMEs.
- Ownership of quality records (Deviations, Change Controls and CAPAs) on behalf of the Validation Department.
- Supporting Validation activities during Technology Transfer of new systems.
- Contributing to the maintenance of overall department KPIs relating to validation of equipment, facilities, utilities, processes and computerised systems.
Qualifications
- A degree (or equivalent) in a Science / Engineering or related discipline.
- Experience in laboratory systems qualification, including automated systems.
- Strong background on validation of systems with CSV component.
- Proven experience within the generation/execution of equipment validation lifecycle documents (URS, DQ, IQ, OQ, PQ, RQ & RTM)
- A working knowledge of the current standards, GMP regulations and industry guidelines as they relate to qualification/validation of GMP systems.
- Experience of working within a GMP Quality Management System.
- Highly organised individual with a proven ability for problemâsolving, thoroughness and good teamwork.
- Demonstratable effective oral, written & interpersonal skills.
- The ability to adapt to changes in priorities and meeting timelines.
- Highly motivated individual with ability to identify and implement continuous improvement activities
About Us
OXB is a quality and innovationâled 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.
OXB collaborates with some of the worldâs most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adenoâassociated virus (AAV) and adenoviral vectors. OXBâs worldâclass capabilities span from earlyâstage development to commercialisation. These capabilities are supported by robust qualityâassurance systems, analytical methods, and depth of regulatory expertise.
Why Join Us?
- đ§ Wellbeing programmes that support your mental and physical health
- đ Career development opportunities to help you grow and thrive
- đ€ Supportive, inclusive, and collaborative culture
- đ§Ș Stateâofâtheâart labs and manufacturing facilities
- đ A company that lives its values: Responsible, Responsive, Resilient, Respect
We want you to feel inspired every day. At OXB, weâre futureâfocused and growing fast. We succeed togetherâthrough passion, commitment, and teamwork.
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Validation Specialist, Equipment, Facilities & Utilities. employer: Oxford Biomedica
Contact Detail:
Oxford Biomedica Recruiting Team
StudySmarter Expert Advice đ€«
We think this is how you could land Validation Specialist, Equipment, Facilities & Utilities.
âšTip Number 1
Familiarise yourself with GMP regulations and industry guidelines specific to validation. Understanding these standards will not only help you in interviews but also demonstrate your commitment to the role.
âšTip Number 2
Network with professionals in the cell and gene therapy sector. Attend relevant conferences or webinars to connect with potential colleagues and learn more about the latest trends and challenges in validation.
âšTip Number 3
Prepare to discuss your experience with validation lifecycle documents in detail. Be ready to share specific examples of how you've contributed to URS, DQ, IQ, OQ, and PQ processes in previous roles.
âšTip Number 4
Showcase your problem-solving skills during the interview. Think of scenarios where you've had to adapt quickly to changes in project priorities and be prepared to discuss how you managed those situations effectively.
We think you need these skills to ace Validation Specialist, Equipment, Facilities & Utilities.
Some tips for your application đ«Ą
Understand the Role: Before applying, make sure you fully understand the responsibilities and requirements of the Validation Specialist position. Familiarise yourself with terms like URS, DQ, IQ, OQ & PQ, as well as GMP regulations.
Tailor Your CV: Customise your CV to highlight relevant experience in validation processes, equipment, and facilities. Emphasise your knowledge of GMP standards and any specific projects that align with the job description.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for the cell and gene therapy sector. Mention specific experiences that demonstrate your problem-solving skills and teamwork abilities, as these are key for this role.
Proofread Your Application: Before submitting, carefully proofread your application materials. Check for spelling and grammatical errors, and ensure that all information is clear and concise. A polished application reflects your attention to detail.
How to prepare for a job interview at Oxford Biomedica
âšKnow Your Validation Lifecycle Documents
Familiarise yourself with the 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.
âšUnderstand GMP Regulations
Make sure you have a solid understanding of current GMP regulations and industry guidelines. This knowledge will demonstrate your capability to ensure regulatory compliance during the interview.
âšShowcase Your Problem-Solving Skills
Prepare examples that highlight your problem-solving abilities and how you've successfully navigated challenges in previous roles. This is particularly important in a fast-paced environment like validation.
âšEmphasise Teamwork and Communication
Since the role involves active participation in cross-functional meetings, be ready to discuss your teamwork and communication skills. Share experiences where you effectively collaborated with others to achieve project goals.
