Validation Specialist in Elstree

Kedrion Biopharma UK is seeking a Validation Specialist to join the Validation team at our Elstree site on a 12 months fixed term contract. This is a key opportunity to play an active role in a highly regulated, fast‑moving biopharmaceutical setting where quality, compliance, and continuous improvement guide every decision.

Working closely with cross‑functional colleagues, you will support science‑ and risk‑based validation activities that uphold product quality, patient safety, and data integrity. This role is best suited to a proactive and detail‑driven professional who thrives in a GMP environment, enjoys managing competing priorities, and values contributing to operational excellence. Please note that our site is not easily accessible by public transport, and this position is fully on‑site.

What you'll do:

• Ensure you and all personnel within your remit comply with applicable Environment, Health & Safety requirements.
• Hold shared responsibility for ensuring assets within your scope remain compliant with regulatory standards and operate without disrupting routine business activities.
• Maintain validation equipment in a calibrated and verified state, ensuring all supporting records are readily accessible.
• Work in continued partnership with Validation Management to align resources with evolving business needs and priorities.
• Support the implementation of validation strategies that utilise the most suitable internal or external personnel while maintaining quality standards.
• Highlight and communicate risks to product quality, patient safety, and data integrity throughout the validation lifecycle, applying a robust quality risk management approach.
• Use risk‑and science‑based tools to enable efficient execution and provide support for issue resolution.
• Identify skills and competency needs within the validation team and support training and development through local training processes.
• Assist Validation Management with resource planning, recruitment, and onboarding of both permanent and contract personnel.
• Ensure personnel operating under your remit perform to required competence and behavioural standards.
• Take ownership of verification and validation activities within your area and collaborate across the validation team to deliver consistent services and implement systemic improvements.
• Support management in planning and effectively utilising operational and capital budgets related to validation activities.
• Promote a culture of continuous improvement by contributing to the evolution of validation processes to enhance efficiency and uphold best practices.

Qualifications and need-to-know:

• Degree‑level qualification in a science or engineering discipline, or equivalent.
• Significant experience in validation within a parenteral biopharmaceutical or blood‑product manufacturing environment (API and/or fill/finish).
• Demonstrated willingness for self‑directed learning and the ability to incorporate new knowledge into routine work.
• Natural inclination toward continuous improvement.
• Ability to work fully on‑site at the Elstree facility.