Senior Verification Engineer

Are you a Senior Verification Engineer with a passion for product development?

Biotage is developing innovative and effective solutions and platforms for the Pharma, BioPharma, Biotech, Diagnostic and Environmental industries. Biotage’s products help our customers’ workflow in the development of new medicines and therapies as well as during analyses of samples, from biological to environmental and food samples.

The Verification and Validation (V&V) team within R&D is now expanding to meet the increased customer demands. 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 and provide objective evidence that the requirements are fulfilled. Requirement management, risk analysis and traceability matrix are tools that we use in the process.

As a Senior 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 and external stakeholders. Product care tasks (improvements to the existing product portfolio) are also central to the role. You will independently run small projects and tasks aimed at improving our existing products.

Biotage offers a creative and global work environment where you work together with stakeholders in regional marketing, our international R&D, supply chain, the global service team and customer support. As a Senior Verification Engineer, you will be part of Biotage R&D and report to the Director of Verification & Validation (V&V), based at Biotage Headquarters in Uppsala, Sweden.

Job scope outline

• 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

Education and Experience

• 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 working with ISO 9001, ISO 13485 is a merit
• Experience as a verification, test or project lead is a merit
• Experience from a controlled business or good documentation practice from elsewhere
• Experience with working with agile methods and Lean methodology is a merit

Desired skills and qualities

• 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

Application

Submit your application no later than August 31. Attach CV and personal letter. Selections will take place on an ongoing basis throughout the application period.