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Senior Validation Specialist

Employer
Oxford BioMedica (UK) Limited
Location
Oxford
Salary
Competitive
Start date
25 Aug 2021
Closing date
24 Sep 2021

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Job Details

Job description:
 

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 Sr Validation Specialist to join the team.  The purpose of this role is to support GMP manufacturing and laboratory facilities by ensuring all aspects of validation (manufacturing & laboratory equipment, facilities and utilities qualification and routine requalification activities, cleaning validation, computerised systems validation and process validation) are complete, up to date and available for review during client and regulatory audits.

 

Your responsibilities in this role would be:

  • Provides subject matter expertise (SME) in relation to the validation/qualification of a wide range of critical/key 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
  • Assists system owners with system/equipment URS and DQ documents and uses a risk-based approach to determine the appropriate validation requirements
  • Creates, reviews, approves and executes validation protocols (equipment, facilities, utilities, computerised systems and manufacturing processes) to meet defined timelines
  • Generates, reviews and approves validation reports in a timely manner on completion of validation activities
  • Manages ongoing validation reviews and re-qualifications/revalidations to ensure maintenance of the ‘validated state’ and continuing GMP compliance.

               

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

  • Bachelor degree in a relevant scientific, engineering or related discipline
  • Extensive experience in validation gained within GMP manufacturing/analytical environments in biopharmaceuticals or pharmaceuticals.
  • Experience in cell/gene therapy, aseptic processing and/or ‘fill & finish’ environments would be an advantage.
  • Strong team-orientation with a proven ability to coach/mentor and lead less experienced members of the validation team in project-related activities.
  • Proven ability to work in multi-project environments, identify priorities and work collaboratively, utilising effective time management skills, to deliver results within predefined timescales.
  • Excellent spoken English communication skills 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

 


Profile description:

 

 

 

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

 

 

  • Bachelor degree in a relevant scientific, engineering or related discipline
  • Extensive experience in validation gained within GMP manufacturing/analytical environments in biopharmaceuticals or pharmaceuticals.
  • Experience in cell/gene therapy, aseptic processing and/or ‘fill & finish’ environments would be an advantage.
  • Strong team-orientation with a proven ability to coach/mentor and lead less experienced members of the validation team in project-related activities.
  • Proven ability to work in multi-project environments, identify priorities and work collaboratively, utilising effective time management skills, to deliver results within predefined timescales.
  • Excellent spoken English communication skills 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

 


We offer:

 

 

 

We are committed to offering highly competitive reward packages for all our staff. That’s why, every year, we benchmark our salaries and benefits against the local pharmaceutical market – by that, we mean that we compare our packages with those of other major companies in the London, Oxford, Cambridge areas.

 

 

We’re looking for highly skilled, focused individuals to help us deliver life-changing therapies to patients. It’s no mean feat, and we have to work together to make this happen.

Along the way, you’ll have a rich variety of opportunities to really develop your career. We’ll also give you a generous set of employee benefits and a competitive salary.

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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