Quality Validation Specialist in Hatfield

Eisai is a leading research-based pharmaceutical organisation with an extensive portfolio across the Oncology, Neurology and Pain therapy areas. Eisai Manufacturing is the hub of Eisai’s production and supply chain. We make tablets, package these into blisters, label and pack vials and bottles. We also manage the wider medicines supply chain and other companies who undertake work on our behalf. By joining Eisai, you will be working for an organisation with a human healthcare philosophy, which means that we put the patient first in everything we do.

Your new role

This role is responsible for providing Quality oversight, validation expertise and strategic support for the successful delivery of EML’s facility expansion projects. The role ensures that all qualification and validation activities associated with new facilities, utilities, warehouse operations, and packaging lines are planned and executed in accordance with EML procedures, regulatory expectations, and industry standards. The job holder will support the development and implementation of validation strategies for the new UK cold-chain warehouse, new vial packaging line, new auto-injector packaging line, and associated facility and utility upgrades, ensuring compliance with GMP, GDP, Annex 15, GAMP 5, and EMLs procedures. The role will provide Quality review and approval of validation documentation, risk assessments, commissioning and qualification deliverables, and ensure that systems, equipment, and facilities are introduced in a compliant and controlled manner. It will also contribute to the creation, review and maintenance of validation-related policies, procedures and templates to ensure they remain aligned with current regulatory and project requirements. The job holder will act as a Quality Subject Matter Expert (SME) for qualification, validation, and CSV within the scope of the facility expansion projects, ensuring the application of data integrity principles and supporting successful project execution from design through to handover and operational readiness. This is a 1yr salaried fixed term contract.

What are we looking for?

• Ability to establish and maintain effective working relationships and communication links within EML, affiliated organisations and other customers
• Ability to understand and analyse user requirements to facilitate changes and system improvements
• Proficient knowledge of electronic systems, CSV and GAMP requirements
• Working knowledge of facility and utility systems such as HVAC, compressed air, environmental monitoring systems
• Good understanding of the requirements of data integrity and application to system management
• Good understanding of Quality Control Systems and analytical software and electronic Quality Systems
• Good technical and scientific judgement
• Ability to interpret complex data and present key findings
• Ability to describe technical information in easy-to-understand terms
• Computer literate e.g. Word, Excel and PowerPoint
• Good understanding of GMP Guidelines and Regulations
• Knowledge of the qualification and validation requirements for equipment and electronic systems
• Maintain knowledge and understanding of technical advancements in electronic systems

What we offer in return

Eisai offers a competitive salary and excellent wider benefits package that includes:

• Electric charging points for Electric/Hybrid vehicles
• Discretionary Bonus
• Free onsite parking
• Subsidised onsite restaurant and coffee shop
• Learning and development opportunities
• Well-being & mental health awareness programmes
• Multi-faith prayer room

You will also be based out of our excellent EMEA Knowledge Centre (EKC) facility, which is our EU Headquarters, and offers an inclusive, and collaborative working environment.

Eisai Recruitment Statement

Diverse perspectives and experiences are critical to our success, and we welcome applications from all people from all backgrounds with the experience and skills needed to perform this role. We look forward to receiving your application. We believe that diverse and inclusive teams promote wellbeing, learning and innovation, helping Eisai serve our patients, their families, our employees, and society. Our commitment is:

• to embrace and celebrate our differences, respecting and valuing each other.
• to include equity, diversity, and inclusion practices in all that we do so everyone has a full sense of belonging.
• to value individual talent where every employee can be themselves and thrive in an environment of openness, trust, and integrity.