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Validation Engineer (CSV)

Job Description

Validation Engineer (CSV)

Do you want to join us in helping to fight the world’s most threatening diseases and enabling access to care for more people around the world? At Siemens Healthineers, we pioneer breakthroughs in healthcare.  For everyone. Everywhere.

We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally. Sound interesting? Then come and join our team as a Validation Engineer – Computer Systems Validation (CSV) to serve as the technical expert for the Computer Systems/Software Validation process to ensure compliance.

Our Healthcare Diagnostics business is based at our site in Sudbury, Suffolk. Recently celebrating 80 years of manufacturing excellence, our Sudbury site designs and assembles blood, urine and diabetes analysis instruments.


This is a 12 month fixed term contract.

As a Validation Engineer, you will be responsible for:

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

Required skills to have for the success of this role

  • Significant experience with Commissioning and Validation within Bio/Pharm/Medical industry with focus on Computer System Validation (CSV).
  • Fluent in cGMP principles.
  • Thorough 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
  • Thorough understanding of the principles of validation (e.g. V Model).
  • Solid project management experience 
  • Good analytical, problem-solving, and investigating skills

Being part of our team

Based on multiple sites in Chilton Industrial Estate, Sudbury, we design and assemble blood, urine and diabetes analysis instruments. With our point-of-care testing systems, Siemens Healthineers delivers lab-accurate, actionable, and timely results on the spot. You can find more information here.

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.

Our culture: We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible, to improve people’s lives around the world.  We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success.

Siemens Healthineers has been Certified™ as a ‘great place to work’.  We are inspired to transform the way things are done – because we want what is best for our people, our customers, and ultimately to help everyone live longer and healthier lives. To find out more about our business and recent news, please explore our website.

Benefits:

  • A competitive salary
  • Generous pension contributions
  • 26 days holiday
  • Access to our flexible benefits from private medical insurance to dental cover
  • Corporate Social Responsibility opportunities including 2 paid volunteering days per year
  • Support from our 24/7 employee assistance programme

We recognise that building a diverse workforce is critical to the success of our business. We strongly encourage applications from a diverse talent pool and welcome the opportunity to discuss flexibility requirements with our applicants to encourage agile working.


Organization: Siemens Healthineers

Company: Siemens Healthcare Diagnostics Manufacturing Ltd

Experience Level: not defined

Job Type: Full-time

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