Equipment & Systems Compliance Specialists

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 Manufacturing Equipment & Systems Specialist to join our Manufacturing Team . In this role, you will ensure compliance of GMP Equipment & Systems within the manufacturing department enabling efficient batch delivery against production schedule in line with GMP, safety and environmental requirements, playing a key part in advancing our mission and making a real difference.

Please note that this role is an onsite opportunity. Your responsibilities in this role would be:
Generating and reviewing of periodic Asset documentation including audit trails, Asset Folders, and User Access levels Maintaining access control for manufacturing and ensuring trained personnel and host access to support Validation / Engineering activities Supporting in progressing of Validation Lifecycle documents and activities for assets (URS, DQ, RQ, VRRs, CST etc) Generating and updating of asset documentation e.g. equipment logbooks, SOPs Providing technical support and point of contact for queries / data from internal departments e.g. Validation and support QMS, and Audits and Client requests Liaising with Equipment & Systems vendors to resolve any technical issues that are identified Executing NPI actions which relate to equipment introduction or modification Supporting the implementation and review of HAZOPs Acting as the subject matter expert where required for QMS and supporting/taking ownership of QMS records for equipment and Systems We are Looking For: A-Level, preferably science based with previous industrial experience Graduate in STEM subject (preferred) Experience working in a GMP environment Experience working with of Cell & Gene therapy manufacturing equipment and systems.

e.g. bioreactors, chromatography, clean rooms etc. Ability to travel across all Oxfordshire sites Willingness to working within Cleanroom environment when required

About Us:

OXB 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
30years of experience in viral vectors; the driving force behindthe majority ofgene therapies. OXB collaborates with some of the worlds most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturingexpertisein lentivirus, adeno-associated virus (AAV) and adenoviral vectors. OXBs 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.

Why Join Us? Competitive total reward packages Wellbeing programmes that support your mental and physical health

Career development opportunities to 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. AtOXB,were future-focused and growing fast. We succeed together through passion, commitment, and teamwork. Ready to Make a Difference? Collaborate. Contribute. Change lives.