Design Validation Scientist Full-time

Design Validation Scientist

Assay Development NGS, in the Highplex department within R&D, develop immunoassays for Olink's Highplex products and evaluate assay performance throughout new product introduction projects (NPI projects). We are currently seeking a Design Validation Scientist to join the Assay Development NGS section.

The Design Validation Scientist will plan, coordinate, and execute Design Validation activities for new product development programs within Thermo Fisher Scientific's Product Commercialization Process (PCP). This role ensures that products meet customer requirements, intended use, and commercialization objectives through effective validation strategies and execution.

The Design Validation Scientist works cross-functionally with Project Management, Operations, Product Management, Quality and other R&D Departments

Key Responsibilities

• Develop and execute Design Validation strategies, plans, protocols, and reports.
• Ensure that validation activities are executed in accordance with approved plans and protocols.
• Ensure that Design Validation activities meet Customer Requirements and intended use.
• Identify risks, drive issue resolution, and ensure timely completion of validation deliverables.
• Partner with Product Management and R&D to understand customer needs and translate them into effective validation approaches.
• Coordinate validation activities across internal teams and external test sites when applicable.
• Drive Design Validation readiness reviews and support Design Validation Results Reviews.
• Maintain traceability between Customer Requirements and Design Validation results.

Qualifications

• PhD in Engineering, Life Sciences, Biotechnology, Chemistry or related technical field.
• Several years of proven experience in product development and R&D environments. Experience of immunoassay product development, qPCR and NGS techniques is advantageous.
• Strong understanding of product development processes, design controls, and risk management.
• Familiarity with Customer Requirements, Product Requirements, and traceability practices.
• Analyze validation data and communicate results, risks, and recommendations to project teams and leadership.
• Experience leading product validation, verification & validation (V&V), or product development activities.
• Demonstrated ability to lead cross-functional teams and influence without direct authority.
• Excellent communication, project management, and problem-solving skills.
• Knowledge of validation regulations and requirements is advantageous.
• Ability to adapt in a dynamic environment.
• English language proficiency required, Swedish beneficial.

At Olink, Thermo Fisher Scientific, you will be part of a nurturing team that values integrity, innovation, and involvement. We offer an encouraging environment where you can thrive and excel in your career and where diverse experiences and perspectives are appreciated. Come aboard and contribute significantly to global health and safety!

If you believe you're the right fit for this role, we encourage you to submit your resume along with a cover letter highlighting your relevant experience. The last day for applications is on the 31st of July. Please note that no screening or interviews will occur until the beginning of August due to the summer holiday season.

At Olink, Thermo Fisher Scientific, you will be part of a nurturing team that values integrity, innovation, and involvement. We offer an encouraging environment where your diverse experiences and perspectives are appreciated, enabling you to thrive and excel in your career. Come aboard and contribute significantly to global health and safety!