Validation Specialist, Equipment, Facilities & Utilities.

We are currently recruiting for a Validation Specialist to join the team for a maternity cover period of up to 12 months.

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.,

• 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.
  
  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 facilities, 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.
  
  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


• Wellbeing programmes


• Development opportunities


• 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.

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., 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.

Oxford Biomedica, a FTSE4Good constituent, is headquartered in Oxford, UK. It has locations across Oxfordshire, UK and near Boston, MA, US. Learn more at www.oxb.com, www.oxbsolutions.com, and follow us on LinkedIn, Twitter and YouTube.

Life at Oxford Biomedica

We value everyone's unique contribution, we appreciate everyone's individuality, and every job matters.

Your contributions are recognised and appreciated. Your work-life balance matters. We recognise, develop and use your strengths. It's a place where you are valued as a whole person, as an individual and as part of a team.

No matter who you are, or what you do, your work will make a significant difference.

We go the extra mile, every day, because we truly care. We work together as a team to achieve our life changing therapies. Our talented colleagues help to build other people's futures, so can you. We empower each other to be our best.

We have access to like-minded scientists and engineers, working in the latest technologies.

Our community of experts create new life-saving cures. Shaping the business' future through collaboration. Our people are on a continuous professional development journey aided by a thought-provoking environment. A place for experts to be stretched, and future experts to be nurtured. We inspire creativity and deliver great science, and so can you.

Our supportive culture invites talent, while creating future innovators.

We'll give you a place where you can learn, grow and contribute to the future of cell and gene therapy. We create opportunities and invest in our people, promoting ongoing learning. Our defined career pathways provide opportunities for everyone to achieve their career potential. We make a difference, and so can you.