Validation Specialist

1 week ago

Oxford Oxfordshire Oxford Oxfordshire OX LT, Oxford, United Kingdom OXB Full time

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.

We are currently recruiting for a Validation Specialist to join the team. This opening provides an exciting opportunity 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 manufacturing.

Operating as part of the Validation Department, the Process & Sterile team is responsible for the generation, execution and reporting of deliverables relating to GMP manufacturing processes (Process Validation), validation of sterile processes (Media Fills, VHP cycle qualification, dry heat cycle qualification), and validation of supporting processes (decontamination assurance). The team additionally provides support for the wider Validation Department work streams and projects, as required.

Your responsibilities in this role would be:

  • Preparation and execution of validation protocols and reports for Process Validation/Process Performance Qualification (PPQ).
  • Preparation and execution of validation protocols and reports for ancillary Process Validation studies (e.g. hold time validation, mixing studies).
  • Providing SME support from Validation for associated product commercialisation activities (e.g. Process Characterisation, Control Strategy development, Continued Process Verification).
  • Preparation and execution of protocols for Sterile Processes and associated activities, and subsequent reporting.
  • 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 during Technology Transfer of new manufacturing processes, including validation of decontamination processes and manufacturing equipment qualification, as required.
  • Contributing to the maintenance of overall department KPIs 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 manufacturing processes, sterile processes, and manufacturing systems.
  • Demonstrable experience of the validation of manufacturing processes in a biopharmaceutical, pharmaceutical or related industry.
  • Working knowledge of the validation of sterile processes and associated activities.
  • 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 changes in priorities and meeting timelines.
  • Other desirable experience includes the generation/execution of equipment validation lifecycle documents (URS, DQ, IQ, OQ, PQ & RTM) and a working knowledge of Cleaning Validation.

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 25 years of experience in viral vectors; the driving force behind the majority of gene therapies.

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.

What’s in it for you:

  • Highly competitive total reward packages
  • Wellbeing programmes
  • Development opportunities
  • Welcoming, friendly, supportive colleagues
  • A diverse and inclusive working environment
  • Our values are: Responsible, Responsive, Resilient, Respect
  • 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.

Collaborate. Contribute. Change lives


We offer:

Oxford Biomedica 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, Oxford Biomedica has more than 25 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 patient’s 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).

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.

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