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Sterilization Validation Engineer
Job in
Town of Sweden, Monroe County, New York, USA
Listed on 2026-10-14
Listing for:
RED Global
Full Time
position Listed on 2026-10-14
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering
Job Description & How to Apply Below
Location:
Sweden (onsite) Type:
Permanent
Start Date:
2026
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
- 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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