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Principle Validation Specialist

Employer
Oxford BioMedica (UK) Limited
Location
Oxford
Salary
Competitive
Start date
12 Apr 2021
Closing date
29 Apr 2021

View more

Discipline
Manufacturing, Validation
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

Do you want to develop your career in exciting new medical technologies? We deliver life-changing gene therapies to patients, and so can you.

Oxford Biomedica’s Validation team is responsible for the qualification, re-qualification and validation activities of the GxP facilities, including equipment, systems and processes.

We are currently recruiting for a Principal Validation Specialist to join the team.  The purpose of this role is Lead both cross-functional and validation departmental teams and actively participates in the execution of validation activities for high value, high criticality/complexity validation projects.

Your responsibilities in this role would be:

  • Provides subject matter expertise (SME) in relation to the validation/qualification of a range of high value, high criticality/complexity OXB systems, equipment and processes
  • Creates and maintains validation master plans, schedules to ensure that all equipment, facilities, utilities and processes are maintained in a qualified state to support GMP requirements
  • Leads and supports system owners with system/equipment URS and DQ documents and uses their subject matter expertise and a risk-based approach to determine the appropriate validation requirements
  • Creates, reviews, approves and executes validation plans, IQ/OQ/PQ protocols and test scripts for equipment, facilities, utilities, computerised systems and manufacturing processes in a timely manner to meet pre-defined requirements.
  • Generates, reviews and approves validation reports in a timely manner to meet project plans/timelines on completion of validation activities
  • Manages validation review, requalification and revalidation programs/schedules to ensure maintenance of the ‘validated state’ and ongoing GMP compliance.

To be successful in this role, you will have the following skills and experience:

  • BSc (or higher) in a relevant scientific or engineering discipline and/or equivalent level work experience
  • Understanding and experience within a steriles/fill Finish is essential and knowledge of VHP.
  • Extensive knowledge and experience of the qualification/requalification/validation in one or both of the following areas:
    • bulk biologics substance and/or biologics product GxP facilities, utilities, systems, equipment and manufacturing processes
    • pharmaceuticals/biologics product GxP analytical testing facilities, utilities, systems and equipment
  • A working knowledge of the current standards and regulations and guidelines as they relate to qualification/validation of equipment/systems, facilities, utilities and processes
  • Proven experience coaching and mentoring less experienced validation specialists
  • Excellent spoken English communication and proven influencing skills at varying levels within the organisation, across functions and multiple project teams
  • Excellent written English communication skills and extensive experience in authoring and reviewing the full range of validation lifecycle documentation.

Do you want to feel inspired every day? We’re future-focused and our business is growing rapidly. We succeed together through passion, commitment and team work, and so can you.

No agencies please

 

 

Company

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.comwww.oxbsolutions.com, and follow us on LinkedInTwitter 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.

Company info
Website
Telephone
+44 (0) 1865 783 000
Location
Windrush Court
Transport Way
Oxford
OX4 6LT
United Kingdom

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