Sterilization Validation Engineer / Sterilization Validation Engineeress

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 and biotech manufacturer. You will work closely with Manufacturing, Engineering, Quality, and other stakeholders to 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. If you enjoy solving complex problems and can drive activities from concept through execution while maintaining a strong compliance mindset, we want to hear from you!

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 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.

Apply online using the form below. Please note that only applications matching the job profile will be considered.

Interested in Finding Out More?

We look forward to hearing from you!