Title of Post: / Validation Specialist
Department: / Validation
Category / Description / Essential / Desirable / Assessment Method
Skills &
Abilities /
  • Subject Matter Expertise in …CSV, Sterilisation/Depyrogenation processes, Process Validation.
/  / Technical Assessment
  • Proactive in ensuring you and the personnel (internal and external) operating under your remit comply with all applicable Environment, Health & Safety requirements.
/  / Validation Management Interview
  • Be committed to, and passionate about, providing a reliable and compliant service to meet and exceed the customer’s needs.
/  / Validation Management Interview
  • The job holder is expected to demonstrate a willingness to engage in self-directed learning, an ability to assimilate new information into their routine working practices and a desire to develop their level of experience and expertise with the aim of developing towards a more senior role.
/  / Validation Management Interview
  • A natural tendency towards continuous improvement is required. It is an expectation that Validation processes evolve both to adopt best practices and to maximise the efficient deployment of resources.
/  / Validation Management Interview
  • Ability to present publicly to senior management.
/  / Validation Management Interview
  • Data analysis with a high level of accuracy.
/  / Technical Assessment
  • Competent in the use of MS Office packages (i.e. Excel and Word)
/  / Validation Management Interview
  • Competent in the use of MS Office packages (i.e. PowerPoint, Visio and Project)
/  / Validation Management Interview
  • Advanced in the use of MS Office packages (i.e. Excel)
/  / Validation Management Interview
  • Excellent documentation skills.
/  / Technical Assessment
Knowledge & Experience /
  • Significant experience of validation within a parenteral (bio)pharmaceutical or blood products manufacturing environment (API and/or fill/finish).
/  / CV
(pre-interview)
  • Awareness that validation is a service provided to our internal customers to meet their needs while maintaining compliance.
/  / Validation Management Interview
  • Experience of supervising and witnessing qualification activities performed by vendors.
/  / Validation Management Interview
  • Application of risk and science based tools to drive execution strategies and support issue resolution.
/  / Validation Management Interview
  • Presentation of validation packages to regulatory authorities.
/  / Validation Management Interview
Training &
Education /
  • Degree level qualification, science or engineering discipline or equivalent.
/  / HR Confirmation
(pre-interview)
  • Degree in (Bio)Chemical Engineering.
/  / HR Confirmation
(pre-interview)
  • Lean six sigma qualification.
/  / HR Confirmation
(pre-interview)
Other Requirement /
  • Able to attend BPL site to perform the role.
/  / HR Interview
  • Able to work outside of core hours when required to meet business needs.
/  / HR Interview
  • Capable of entering classified manufacturingareas.
/  / HR Interview
  • Able to travel overseas as required to support business needs.
/  / HR Interview