About this opportunity
RED Global lists this Sterilization Validation Engineer opportunity in town of sweden, New York. Review the employer’s description below for duties, qualifications and application requirements.
Job 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
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Who can apply
Review the original listing for work authorization, qualifications and employer requirements.