Validation Specialist, Equipment, Facilities & Utilities.

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Validation Specialist, Equipment, Facilities & Utilities.

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.

We are currently recruiting for a Validation Specialist to join the team. Operating as part of the Validation Department, the general validation group is responsible for the generation, execution and reporting of deliverables relating to GMP systems (equipment, facilities and utilities).

This opening provides an exciting opportunity to participate in high value projects, working alongside cross-functional teams to deliver against company goals. We contribute to the delivery of major customer projects, the ensuring of regulatory compliance for GMP manufacturing and to the continued growth of the company.

Your responsibilities in this role would be:

• Preparation and execution of validation lifecycle documents (URS, DQ, IQ, OQ & PQ) and subsequent reporting.
• Active participation in cross-functional meetings and discussions to provide validation support to internal SMEs.
• Ownership of quality records (Deviations, Change Controls and CAPAs) on behalf of the Validation Department.
• Supporting Validation activities during new manufacturing processes, including equipment, facilities and utilities qualification, as required.
• Contributing to the maintenance of department KPIs and routine validation activities relating to validation of equipment, facilities, utilities, processes and computerised systems.

We are looking for:

• A Degree (or equivalent) in a Science / Engineering or related discipline
• A working knowledge of the current standards, GMP regulations and industry guidelines as they relate to qualification/validation of facilities, utilities and equipment.
• Demonstrable experience of the validation of equipment, utilities and equipment.
• Demonstrable experience in authoring, reviewing and executing validation lifecycle documents, protocols and reports (URS, DQ, IQ, OQ & PQ).
• Experience of working within a GMP Quality Management System.
• Highly organised individual with a proven ability for problem-solving, thoroughness and good teamwork.
• Demonstratable effective oral, written & interpersonal skills.
• The ability to adapt to rapid changes in project priorities and meeting required timelines.
• Other desirable experience includes the generation/execution of equipment validation lifecycle documents (URS, DQ, IQ, OQ & PQ) and a working knowledge of Cleaning Validation.

About Us:

Oxford Biomedica 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.

Oxford Biomedica 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. Oxford Biomedica’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.

What’s in it for you:

• Highly competitive total reward packages
• Welcoming, friendly, supportive colleagues
• A diverse and inclusive working environment
• Our values are: Deliver Innovation, Be Inspiring and Have Integrity
• State of the art laboratory and manufacturing facilities

We want you to feel inspired every day. We’re future-focused and our business is growing rapidly. We succeed together through passion, commitment and teamwork, and so can you.

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