Validation Specialist

Are you an experienced validation specialist looking to take your expertise to the next level? Join our team in Kent, UK, and play a pivotal role in ensuring compliance with global regulatory standards while driving innovation in validation processes.

As a Validation Specialist, you will be responsible for preparing and executing complex validation projects to ensure compliance with EudraLex Volume 4 – Good Manufacturing Practice (GMP) guidelines and other quality standards. You will analyse validation data, troubleshoot problems, develop procedures, and collaborate with internal teams to maintain high standards.

In addition, you will:
• Perform validation activities for facilities, equipment, and processes in compliance with GMP and other regulatory requirements
• Review and update validation procedures (Policies, Master plans, SOPs)
• Establish and maintain the Validation Master Plan
• Prepare, execute, and report validation protocols, including cleaning validation
• Conduct requalification activities, including temperature mapping of refrigerators, freezers, and incubators
• Maintain the requalification schedule for validated equipment
• Liaise with Engineering, Quality Assurance, and User Departments to ensure timely validation processes
• Monitor regulatory developments and brief relevant personnel on industry updates
• Participate in audits by customers and regulatory authorities

Required Experience & Skills
• Bachelor’s degree in a relevant field
• Minimum 5 years of experience in validation or related area
• Strong knowledge of EudraLex Volume 4, Annex 11 & 15 validation requirements
• Understanding of ISO 9001 and ISO13485 Quality Systems
• Familiarity with IQ, QQ, PQ, PV, and temperature mapping principles
• Experience authoring validation reports and procedures
• Strong knowledge of calibration principles and compliance systems
• Proficiency in Microsoft Word, PowerPoint, and Excel
• Experience in biopharmaceutical cleaning validation and computerised system validation (desired)

If this sounds like you, please apply for immediate consideration.

At Sekisui Diagnostics, we help improve patient outcomes by doing what we’ve always done – focusing on innovating and developing highly accurate diagnostics tests, reagents and systems. In recent years, social and consumer needs for medical care have been diversifying in line with dramatic transformations in the global medical environment. We will continue to embrace change and challenge new frontiers so that we can create unique, high-quality products and services that will leave our customers truly satisfied. With worldwide state-of-the-art manufacturing facilities and an international sales and distribution network, we are a solid partner for healthcare professionals, distributors, and manufacturers around the world. Our global capabilities allow us to meet the specific needs of our wide range of customers – and customize solutions at both a regional and product level.

Sekisui Diagnostics offers a competitive compensation and benefits package.

Equal Opportunities
As an equal opportunity employer, Sekisui Diagnostics is committed to a diverse workforce. Employment decisions will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, other non-job related characteristics or other prohibited grounds specified in applicable country and local laws. It is also Sekisui Diagnostics policy to comply with all applicable country and local laws respecting consideration of unemployment status in making hiring decisions.
Sekisui Diagnostics is pleased to consider all qualified applicants for open roles and encourages candidates to apply online. Only those candidates who are selected for further consideration or interviews will be contacted by a member of the company’s internal recruiting team.

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