Validation Specialist

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).,

• Preparation and execution of validation protocols (Process Validation, 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 department KPIs 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 manufacturing processes, sterile processes, and manufacturing systems.


• Demonstrable experience of the validation of manufacturing processes and sterilisation processes, in a biopharmaceutical, pharmaceutical or related industry.


• 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) and a working knowledge of Cleaning Validation.
  
  We are a quality and innovation-led cell and gene therapy CDMO with a mission to enable our clients to deliver life changing therapies to patients around the world.


Our innovative solutions and proven expertise allow our clients in the biotech and biopharma industry, to deliver life-saving therapies to reach even more patients.

The success of cell and gene therapy products transforms outcomes for millions of people suffering from some of the world's worst diseases and medical conditions.

What's in it for you:


• Highly competitive reward packages


• Wellbeing programmes


• Development opportunities


• A 35-hour working week


• 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 are a quality and innovation-led cell and gene therapy CDMO with a mission to enable our clients to deliver life changing therapies to patients around the world.

Our innovative solutions and proven expertise allow our clients in the biotech and biopharma industry, to deliver life-saving therapies to reach even more patients.

The success of cell and gene therapy products transforms outcomes for millions of people suffering from some of the world's worst diseases and medical conditions.

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.