Validation Specialist - BPL Recruitment

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Jobs: Engineering

Validation Specialist

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 Main Job Purpose:

As part of the Validation team, take ownership of all aspects of service delivery relating to equipment commissioning, qualification and validation within you remit. Ensuring compliance with all applicable (EHS and GxP) regulatory and internal Quality standards and industry best practice. Be committed to, and passionate about, providing a reliable and compliant service to meet and exceed the customer's needs. This is a customer-facing role, and as such the ability to form relationships across the organisation is essential for success.

Key Duties and Responsibilities:

  • Ensure you and the personnel (internal and external) operating under your remit comply with all applicable Environment, Health & Safety requirements.
  • Collective responsibility for the ongoing compliance of all assets at the Elstree facility within your remit, ensuring that the equipment meets regulatory requirements at all times with a target of zero impact to routine operations.
  • Maintain an ongoing dialogue with Validation Management to ensure validation resources are effectively deployed to meet dynamic and competing business priorities.
  • Support the implementation validation strategies that allow the work to be executed by the most appropriate personnel (internal and external) whilst maintaining standards.
  • Highlight risks to product quality, patient safety and/or data integrity throughout the validation lifecycle so that they are understood, transparent and can be managed through the application of a quality risk management approach.
  • Application of risk and science based tools to drive execution strategies and support issue resolution.
  • Identify skills and competency development needs within the team. Support individual and team development through the Elstree training processes.
  • Support Validation Management in the identification, recruitment and on-boarding of resource (staff and contract) into the organisation.
  • Ensure that the performance of the personnel (internal and external) operating under your remit meets the standards (competence and behavioural) required by BPL.
  • Ownership of commissioning, qualification and validation implementation within your remit and, in conjunction with your peer group, across the validation team to ensure consistent service delivery and systemic application of process improvements.
  • Directly assist the Validation Management in ensuring that adequate budget (opex and capex) is planned and spent in support of the validation team.
  • Maintain your area of responsibility in a state of inspection readiness at all times and preparation and presentation of validation packages to regulatory authorities.
  • Escalation to Validation Management, at the earliest opportunity, when issues or obstacles that impact compliance or on time delivery.

All other tasks and duties, as necessary, to maintain the effectiveness of the validation service as required by the business and/or Validation Management.

Skills and Experience:

  • Significant experience of validation within a parenteral (bio) pharmaceutical or blood products manufacturing environment (API and/or fill/finish)
  • 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.
  • A natural tendency towards continuous improvement is required. It is an expectation that Validation processes evolve both to assure best practices and to maximise the efficiency of site resources.
  • Excellent documentation skills.

Training and Education:

  • Education
  • Degree level qualification, science or engineering discipline or equivalent. 







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