Sterilization Validation Engineer

RED Global; Town of Sweden (NY); Hybrid; USD 90,000 - 110,000; Full time

Job summary

RED Global in Sweden is seeking an experienced Validation Engineer to lead validation and qualification activities for sterilization systems and processes in a GMP-regulated environment. You will collaborate with Manufacturing, Engineering, and Quality to ensure compliant, robust validation programs.

This hands-on SME role requires deep knowledge of moist heat sterilization, autoclave validation, VHP decontamination, and lifecycle management, with strong technical writing and cross-functional

Qualifications

• 7+ years in qualification and validation within GMP environments.
• Expertise in moist heat sterilization and autoclave validation.
• Experience with VHP decontamination and controlled environments.

Responsibilities

• Act as SME for autoclave-based moist heat sterilization and VHP decontamination.
• Lead autoclave cycle development, qualification and validation for equipment and products.
• Plan and execute IQ/OQ/PQ, lifecycle validation, and requalification programs.
• Maintain sterilization cycle parameters and process definitions.
• Author, review and approve validation protocols and reports.

Skills

Sterilization science

Validation leadership

GMP compliance

Technical writing

Cross-functional collaboration

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