Validation Specialist

2 Days Old

Company description: OXB is a quality and innovation-led viral vector CDMO that enables its clients to deliver life-changing therapies to patients around the world. One of the original pioneers in cell and gene therapy, OXB has more than 30 years of experience in viral vectors, the driving force behind the majority of gene therapies. Cell and gene therapy is the treatment of disease by the delivery of therapeutic genetic material (DNA or RNA), into a patients cells. One highly effective approach to delivering genetic information is to re-engineer existing viruses to be safe delivery vehicles (vectors) to insert the genetic material into patients cells. This can be achieved either by directly administering the vector to the patient (often referred to as in vivo gene therapy), or by first introducing the genetic material to cells or tissue outside of the body, before administering the cells or tissue into the patient (often referred to as ex vivo gene therapy or gene-modified cell therapy). OXB 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. OXB'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. Job description: Join Us in Changing Lives At OXB , our people are at the heart of everything we do. Were on a mission to enable life-changing therapies to reach patients around the worldand were looking for passionate individuals who embody our core values every day: Responsible, Responsive, Resilient, and Respectful . Were currently recruiting for a Validation Specialist to join our Validation Equipment team. In this role, you willhave theopportunity to participate in high value projects, working alongside cross-functional teams to deliver company goals, contribute to the delivery of major customer projects and the ensuring of regulatory compliance for GMP systems, playinga key part in advancing our mission and making a real difference. Your responsibilities in this role would be: Preparation and execution of validation deliverables for GMP systems. Providing SME support from Validation for project activities related to GMP systems. Active participation in cross-functional 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 duringTechnology Transfer of new systems. Contributing to the maintenance of overall department KPIs relating to validation of equipment, facilities, utilities, processes and computerised systems. Profile description: We are looking for: 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 withinthe 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 aproven ability for problem-solving, 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 We offer: Why Join Us? Competitive total reward packages Wellbeing programmesthat support your mental and physical health Career development opportunitiesto help you grow and thrive Supportive, inclusive, and collaborative culture State-of-the-art labs and manufacturing facilities A company that lives its values: Responsible, Responsive, Resilient, Respect We want you to feel inspired every day. At OXB, were future-focused and growing fast. We succeed togetherthrough passion, commitment, and teamwork. Ready to Make a Difference? Collaborate. Contribute. Change lives.

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Location:
Gb
Job Type:
FullTime
Category:
Consulting

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