Validation Engineer Sterilization (MS&T)

Q-Med Aktiebolag; Uppsala kommun; Vor Ort; SEK 700.000 - 1.000.000; Vollzeit

Zusammenfassung

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

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Sterilization

Autoclave validation

VHP decontamination

cGMP knowledge

Technical writing

Cross-functional collaboration

Root cause analysis

Ausbildung

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

Jobbeschreibung

Kommun: Uppsala

At Galderma, we are advancing dermatology for every skin story. We are now looking for a highly experienced Validation Engineer Sterilization to join our MS&T team in Uppsala. This is a key role for someone who wants to combine deep technical expertise with cross-functional collaboration in a highly regulated manufacturing environment.

In this position, you will act as the subject matter expert for sterilization processes with a particular focus on autoclaves with moist heat sterilization and VHP (Vaporized Hydrogen Peroxide) decontamination systems.

You will play a critical role in ensuring that sterilization processes remain compliant, scientifically sound, and in a validated state throughout the product lifecycle, supporting patient safety and product quality.

The Role

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.

Who You Are

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.

Why Galderma?

At Galderma, you'll have the opportunity to work in a company dedicated to innovation, quality, and improving patient outcomes. You will join a collaborative and science-driven environment where your expertise will have a direct impact on product quality, operational excellence, and the future growth of our Uppsala site.

We look forward to hearing from you.

Q-MED AKTIEBOLAG

SEMINARIEGATAN 21

75228 UPPSALA

Uppsala Kommun