Sterilization Validation Engineer

Red Commerce Schweiz GmbH; Town of Sweden (NY); On-site; USD 70,000 - 95,000; Full time

Job summary

more-jobs is seeking a Validation Engineer - Sterilization for a Sweden onsite permanent role. You will lead validation activities across sterilization systems, collaborating with Manufacturing, Engineering and Quality to ensure regulatory compliance and industry best practices.

The ideal candidate has 7+ years in GMP qualification and sterilization science, with deep expertise in autoclave validation and VHP decontamination.

Qualifications

• 7+ years of experience in GMP qualification and validation.
• Expertise in moist heat sterilization and autoclave validation.
• Experience with VHP decontamination systems.
• Knowledge of validation methodologies and lifecycle validation.
• Strong technical writing, documentation and communication skills.
• English required; Swedish language is a strong advantage.

Responsibilities

• Act as SME 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.

Skills

Sterilization validation

Autoclave validation

VHP decontamination

Validation methodologies

cGMP knowledge

Technical writing

English proficiency

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