Live opening · Posted 18 hours ago

Validation Engineer Sterilization (MS&T)

Galderma SA · Uppsala
Workday
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At a glance

The key details from the original listing.

Posted 18 hours ago
CompanyGalderma SA
LocationUppsala
SourceWorkday
ListedPosted 18 hours ago

About the role

Description supplied by the original job listing.

Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin, we are in shapes our lives, we are advancing dermatology for every skin story.
We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.
At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.
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.

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