Principle Validation Specialist
- Experience Level
- Experienced (non-manager)
Do you want to develop your career in exciting new medical technologies? We deliver life-changing gene therapies to patients, and so can you.
Oxford Biomedica’s Validation team is responsible for the qualification, re-qualification and validation activities of the GxP facilities, including equipment, systems and processes.
We are currently recruiting for a Principal Validation Specialist to join the team. The purpose of this role is Lead both cross-functional and validation departmental teams and actively participates in the execution of validation activities for high value, high criticality/complexity validation projects.
Your responsibilities in this role would be:
- Provides subject matter expertise (SME) in relation to the validation/qualification of a range of high value, high criticality/complexity OXB systems, equipment and processes
- Creates and maintains validation master plans, schedules to ensure that all equipment, facilities, utilities and processes are maintained in a qualified state to support GMP requirements
- Leads and supports system owners with system/equipment URS and DQ documents and uses their subject matter expertise and a risk-based approach to determine the appropriate validation requirements
- Creates, reviews, approves and executes validation plans, IQ/OQ/PQ protocols and test scripts for equipment, facilities, utilities, computerised systems and manufacturing processes in a timely manner to meet pre-defined requirements.
- Generates, reviews and approves validation reports in a timely manner to meet project plans/timelines on completion of validation activities
- Manages validation review, requalification and revalidation programs/schedules to ensure maintenance of the ‘validated state’ and ongoing GMP compliance.
To be successful in this role, you will have the following skills and experience:
- BSc (or higher) in a relevant scientific or engineering discipline and/or equivalent level work experience
- Understanding and experience within a steriles/fill Finish is essential and knowledge of VHP.
- Extensive knowledge and experience of the qualification/requalification/validation in one or both of the following areas:
- bulk biologics substance and/or biologics product GxP facilities, utilities, systems, equipment and manufacturing processes
- pharmaceuticals/biologics product GxP analytical testing facilities, utilities, systems and equipment
- A working knowledge of the current standards and regulations and guidelines as they relate to qualification/validation of equipment/systems, facilities, utilities and processes
- Proven experience coaching and mentoring less experienced validation specialists
- Excellent spoken English communication and proven influencing skills at varying levels within the organisation, across functions and multiple project teams
- Excellent written English communication skills and extensive experience in authoring and reviewing the full range of validation lifecycle documentation.
Do you want to feel inspired every day? We’re future-focused and our business is growing rapidly. We succeed together through passion, commitment and team work, and so can you.
No agencies please