Validation Engineer Sterilization (MS&T)

As Validation Engineer Sterilization, you will lead and drive validation and qualification activities across sterilization systems and processes. Working closely with Manufacturing, Engineering, Quality, and other stakeholders, you will provide technical leadership and ensure compliance with regulatory requirements and industry best practices. Your responsibilities will include:

• Acting as the SME for autoclave-based moist heat sterilization and VHP decontamination of isolators and controlled environments.

• Leading autoclave cycle development, qualification, and validation activities for equipment, components, and finished products.

• Planning and executing equipment qualification and process validation activities, including IQ/OQ/PQ.

• Maintaining sterilization cycle parameters, load configurations, and process definitions.

• Driving requalification programs and lifecycle management of validated systems.

• Performing thermal mapping, heat penetration studies, biological indicator evaluations, and cold spot identification.

• Establishing and maintaining scientifically justified sterilization cycles aligned with regulatory expectations.

• Authoring, reviewing, and approving validation protocols, reports, risk assessments, deviations, CAPAs, and change controls.

We are looking for a technically strong and quality-focused professional who thrives in a collaborative environment. You enjoy solving complex problems, influencing stakeholders, and driving activities from concept through execution while maintaining a strong compliance mindset. To be successful in this role, you bring:

• A Bachelor's or Master's degree in Engineering, Chemistry, Biochemistry, Biotechnology, Pharmaceutical Sciences, or a related field.

• Approximately 10 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.

• Strong analytical abilities with experience in root cause analysis and risk-based decision making.

Experience from pharmaceutical, biopharmaceutical, medical device, or other regulated manufacturing environments is highly valued. Please note, applications will be reviewed continuously and we may fill the position before the closing date, so we encourage you to apply as soon as possible.