Sterilization Validation Engineer

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 life cycle 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 life cycle 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? Apply now or share your CV to (see below) to book in a confidential call.