Sterilization Validation Engineer

Lead Sterilization Validation and Qualification Activities

Provide technical leadership to drive validation and qualification activities across sterilization systems and processes for a leading pharmaceutical and biotech manufacturer. Working closely with Manufacturing, Engineering, Quality, and other stakeholders, ensure compliance with regulatory requirements and industry best practices. This role is designed 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

Qualifications and Experience

• 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