Description

Validation Engineer - Sterilization Location: Sweden (onsite) Type: Permanent Start Date: 2026 About the Role We are seeking an experienced Validation Engineer to lead and drive validation and qualification activities across sterilization systems and processes for a leading pharmaceutical/biotech manufacturer. Working closely with Manufacturing, Engineering, Quality and other stakeholders, you will provide technical leadership and ensure compliance with regulatory requirements and industry best practices. This is a hands-on subject matter expert role for a technically strong, quality-focused professional who thrives in a collaborative environment, enjoys solving complex problems, and can drive activities from concept through execution while maintaining a strong compliance mindset. Key Responsibilities Act as the Subject Matter Expert for autoclave-based moist heat sterilization and VHP decontamination of isolators and controlled environments Lead autoclave cycle development, qualification and validation activities for equipment, components and finished products Plan and execute equipment qualification and process validation activities, including IQ/OQ/PQ Maintain sterilization cycle parameters, load configurations and process definitions Drive requalification programs and lifecycle management of validated systems Perform thermal mapping, heat penetration studies, biological indicator evaluations and cold spot identification Establish and maintain scientifically justified sterilization cycles aligned with regulatory expectations Author, review and approve validation protocols, reports, risk assessments, deviations, CAPAs and change controls What We're Looking For Approximately 7+ years or more of relevant experience within qualification and validation in a GMP-regulated environment Demonstrated expertise in moist heat sterilization, autoclave validation and sterilization science Experience with VHP decontamination systems and controlled manufacturing environments Strong knowledge of validation methodologies, qualification activities and lifecycle validation Solid understanding of cGMP requirements and regulatory expectations Excellent technical writing, documentation, communication and collaboration skills English required; Swedish is a strong advantage Interested in finding out more?