Senior Validation Engineer - Sterilization (Autoclave VHP)

Q-Med Aktiebolag; Uppsala kommun; On-site; SEK 700,000 - 1,000,000; Full time

Job summary

Q-Med Aktiebolag in Uppsala is seeking a highly experienced Validation Engineer Sterilization to lead validation activities for sterilization systems. You will collaborate with Manufacturing, Engineering, Quality, and other stakeholders to ensure validated, compliant processes that safeguard patient safety and product quality.

The role focuses on autoclave-based moist heat sterilization and VHP decontamination, with responsibility for protocol authoring, qualification execution, and lifecycle

Qualifications

• Bachelor's or Master's degree in Engineering, Chemistry, Biochemistry, Biotechnology, Pharmaceutical Sciences, or related field.
• Approximately 10+ years of qualification and validation experience in a GMP-regulated environment.
• Demonstrated expertise in moist heat sterilization, autoclave validation, and sterilization science.

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 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 ID.
• 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

Autoclave validation

VHP decontamination

cGMP knowledge

Technical writing

Cross-functional collaboration

Root cause analysis

Education

Bachelor's or Master's in Engineering/Chemistry/Biotechnology

Job description

Q-Med Aktiebolag in Uppsala is seeking a highly experienced Validation Engineer Sterilization to lead validation activities for sterilization systems. You will collaborate with Manufacturing, Engineering, Quality, and other stakeholders to ensure validated, compliant processes that safeguard patient safety and product quality.

The role focuses on autoclave-based moist heat sterilization and VHP decontamination, with responsibility for protocol authoring, qualification execution, and lifecycle