Validation Specialist, Equipment, Facilities & Utilities.

OXB; Oxford; On-site; GBP 35,000 - 50,000; Full time

Job summary

Join a pioneering company at the forefront of the cell and gene therapy industry as a Validation Specialist. In this role, you'll be responsible for executing and reporting on validation activities related to GMP systems, supporting major customer projects while ensuring compliance and contributing to the company's growth. Bring your expertise in validation and quality management systems to a dynamic team dedicated to changing lives through innovative therapies.

Benefits

Competitive rewards

Wellbeing programs

Development opportunities

Supportive colleagues and inclusive environment

State-of-the-art facilities

Qualifications

• Experience in validating equipment, utilities, and facilities.
• Knowledge of GMP regulations and industry guidelines.
• Highly organised with strong problem-solving and communication skills.

Responsibilities

• Preparation and execution of validation lifecycle documents.
• Participating in cross-functional meetings for validation support.
• Owning quality records for the Validation Department.

Skills

Problem-Solving

Teamwork

Communication

Education

Degree in Science, Engineering, or related discipline

Job description

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

1. Preparation and execution of validation lifecycle documents (URS, DQ, IQ, OQ & PQ) and reporting.
2. Participating in cross-functional meetings to provide validation support to internal SMEs.
3. Owning quality records such as Deviations, Change Controls, and CAPAs for the Validation Department.
4. Supporting validation activities during new manufacturing processes, including equipment, facilities, and utilities qualification.
5. 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.