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Validation Engineer CSV – Point of Care – Hybrid working

Now’s our time to inspire the future of healthcare together.

Siemens Healthineers is a leading global medical technology company with over 170 years of experience and 18,000 patents. More than 68,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. We stand with our customers around the world to support them in delivering high quality care to their patients. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services. This is what truly matters to us.

The role of Validation Engineer (Computer Systems Validation) has great flexible working with core hours 9-3 and early finish on Friday 12:30 and hybrid working. The hybrid working means we are commutable from areas including Ipswich, Cambridge, Bury St Edmunds, Braintree, and Colchester. We have excellent benefits including, up to 10% employer pension contribution, 26 days holiday + bank holidays + option to buy or sell an additional 5, subsidised health care, bonus scheme, share scheme and many more!

Validation Engineer (CSV)

Join our team now at Siemens Healthineers as a Validation Engineer (Computer Systems Validation) to serve as the technical expert for the Computer Systems/Software Validation process to ensure compliance. Our facility in Sudbury, Suffolk is a global leading manufacturer in the assembly of specialist instrumentation for laboratories and hospitals across the world for Urinalysis, Diabetes, and Blood Gas analytics.

Your mission:

As CSV Validation Engineer, you will be responsible to lead, manage or support validation activities across the Sudbury sites.

Additionally, you will be providing expertise in all aspects of process, equipment and computer system validation and technical support.

Core Validation Requirements

• Assisting system owners with impact assessments and identifying qualification/validation requirements.
• Carrying out all validation activities on equipment, computer systems/software and process
• Conduct Compliance Determinations and GxP Risk Assessments on systems for computer systems/equipment
• Participate/ manage Validation Review Board activities locally

Regulatory Requirements

• 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

EHS

• Ensuring compliance with safety, health and environmental (SHE) legislation.

Teamwork

• Engaging with project teams to help with selection, installation, and commissioning of new equipment.

Quality Assurance

• Competent in the principles of and practical use of the Quality Management Systems.

Skills and Experience:

• Qualified to apply validation standards
• Significant experience with Commissioning and Validation within Bio/Pharm/Medical industry with focus on Computer System Validation (CSV).
• Fluent in cGMP principles.
• Good understanding of GAMP standards, 21 CFR Part 11 and European regulations associated with the medical device industry e.g., ISO 62304, and applicable regulatory guidelines.
• Working experience of validating computer systems/software for use in an FDA regulated environment

At Siemens Healthineers, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose: To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally.