Validation Engineer

Responsibilities

• Perform validation and qualification of computerized systems, processes, and equipment within the Life Science industry
• Take early responsibility in projects, influencing everything from design to commissioning
• Ensure high standards from initial requirements to finished products
• Manage requirements, deviations, and risk management
• Work with requirements specification, documentation, and URS

Requirements

• Engineering degree in biotechnology, medical technology, chemical engineering, computer engineering, or similar
• Experience in Life Science validation, including IQ/OQ/PQ phases
• Experience with requirements, deviation, and risk management
• Experience with requirements specification, documentation, and URS
• Good knowledge of GxP regulations (GAMP5, 21 CFR Part 11, and Eudralex Annex 11 is a plus)
• Fluency in Swedish and English (written and spoken)

Preferred Qualifications

• Experience with digitalization projects or automation within Life Science

About the Company

Knightec Group is one of Northern Europe's leading strategic partners in product and digital service development, helping customers transform new technology into real-world solutions.