Autoclave & VHP 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

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