Validation Engineer
20 hours ago
Leeds
Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions. Apply now for the position of Validation Engineer within the Point of Care Diagnostics business line at our facility in Sudbury. You will be part of the Engineering department driving effective Process Management, continuous improvement and provide engineering / technical support for manufacturing operations. You will manage and support validation activities across all functions with a key emphasis on providing expertise in all aspects of process, equipment and computer system validation and technical support. Your Role: • You will ensure that all validation activities are conducted in accordance with the Site Validation Master Plan (SVMP) and established validation policies and procedures., • Prepare and execute validation protocols. Author, review and approve validation, technical documentation and SOPs., • Assist system owners with impact assessments and identify qualification/validation requirements., • Carry out all validation activities on equipment and systems., • Represent the business in customer audits and regulatory inspections to demonstrate that we have compliant systems., • Maintain compliance with Data Integrity Regulations, GAMP standards, 21 CFR Part 11 and applicable regulatory guidelines., • You will ensure compliance with safety, health and environmental (SHE) legislation, and drive a zero-accident culture., • Validation Protocol Development: Ability to create and execute IQ/OQ/PQ protocols for equipment, utilities, and processes., • Regulatory Knowledge: Familiarity with GMP, FDA, MHRA, ISO standards, and other relevant regulatory guidelines., • Risk Assessment: Experience with FMEA, or similar risk-based approaches., • Equipment & Process Validation: Hands-on experience with manufacturing equipment, cleaning validation, and process qualification., • Computer System Validation (CSV): Understanding of GAMP 5 principles and 21 CFR Part 11 compliance., • Industry Background: Typically 2–5 years in pharmaceutical, medical device, or regulated manufacturing environments., • Validation Lifecycle: Proven experience in planning, executing, and closing validation projects., • Audits & Inspections: Exposure to regulatory audits and ability to defend validation documentation., • Continuous Improvement: Experience with Lean or Six Sigma methodologies is a plus., • 26 days' holiday with the option to buy or sell an additional 5, • Up to 10% employer pension contribution, • Share and bonus scheme, • Access to our flexible benefits from private medical insurance to dental cover