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 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? Apply now or share your CV to mgordon@redglobal.com to book in a confidential call.