Arbetsbeskrivning

Are you a Senior Verification Engineer looking for your next opportunity within product development?

Here you can make your mark and demonstrate how the very best organisations transfer products from R&D into a manufacturing environment.

Biotage is looking for a driven colleague to join our successful Swedish Global Life Science company. Biotage is an industry leader, developing innovative and effective platform products for the Pharma, BioPharma, Biotech, Diagnostic and Environmental industries. Biotages’ products ease our customers’ workflow in the discovery and development of new therapies.

Our open position is within the Verification and Validation (V&V) at R&D. The V&V team is responsible for verification and validation of systems both during product development and within the product care process. The core of the V&V process is to assess the product quality throughout the product life cycle. Requirement management, risk analysis and root-cause analyses are tools that we use in the process. Our primary goal is to ensure that the developed system satisfies its intended use and user needs. Keeping the product lifecycle and quality perspective is important to us.

As a driven and proactive Verification Engineer within V&V, you ensure product quality and efficiency through all phases of the product development. You will work as a verification lead within the project teams to develop new instruments and consumables. The role involves networking with internal stakeholders and working as part of a multi- disciplinary team to deliver the highest quality products and processes.

Product optimisations (improvements to the existing product portfolio) are also key aspects of this role. You will be encouraged to independently run small projects and tasks aimed at improving our existing products.

Biotage offers an innovative, collaborative and fertile work environment where you work and learn with stakeholders in regional marketing, R&D, supply chain, the global service team and customer support, to deliver the very best products and processes. As a valued Verification Engineer, you will be an essential part of Biotage R&D, liaising with and reporting to the Director of Verification & Validation (V&V), based at Biotage Headquarters in Uppsala, Sweden.

We work with newly developed systems, which entail hardware, software and often a consumable (e.g. column for separation). The job involves:

• Lead and perform activities withing the function and develop ways of working.
• Serve as a subject matter expert for quality related issues within product development
• Supervise peers
• Take a hands-on approach to verification and testing and ensure adherence to quality standards
• Define and evaluate system requirements
• Develop test cases from requirements
• Drive, coordinate, perform and evaluate test, verification and validation tasks on a system level
• Document and administrate changes in our product life-cycle management systems
• Perform and review technical investigations (e.g. risk assessments and root-cause analyses)
• Collaborate with team members to troubleshoot issues, optimize performance, and deliver tasks on schedule.
• Actively contribute to, and lead, continuous improvement of ways of working within the team

• Minimum BSc in Systems, Mechanical, Chemical, Electrical Engineering or similar
• Broad experience within verification, validation or testing
• Knowledge in regulatory framework applicable for laboratory equipment (e.g Low Voltage Directive LVD and Machinery Directive MD)
• Skilled in requirement management
• Proficiency in transforming requirements into test cases for verification, as well as generating comprehensive documentation
• Skilled in risk management
• Experience within product development or quality assurance
• Experience from a controlled business or good documentation practice from elsewhere

• Experience working with ISO 9001, ISO 13485
• Experience as a verification, test or project lead
• Experience in project coordination or mentoring
• Experience with working with agile methods and Lean methodology

• To excel in this role, you should possess problem-solving skills and enjoy collaborating with others to achieve qualitative results
• As a person you are driven, independent, curious and proactive
• You have a quality focus and value the importance of product life-cycle management
• Personal drive and commitment are highly valued
• You possess a structured way of working
• Fluent in English, both written and verbally
• Advanced Swedish

We look forward to receiving your application, together with CV and a personal letter, no later than 5th of January 2025. In this recruitment we work together with our consultant Charlotta Babington Thorzelius. If you have any questions regarding the process please contact her on [email protected]