Validation Engineer Sterilization (MS&T)

Galderma; Uppsala kommun; On-site; SEK 700,000 - 900,000; Full time

Job summary

Galderma seeks a highly experienced Validation Engineer Sterilization to join the MS&T team in Uppsala. You will lead validation across sterilization systems, focusing on autoclave moist heat and VHP decontamination to ensure compliant, validated processes throughout the product lifecycle.

You will collaborate with Manufacturing, Engineering, Quality and other stakeholders, drive lifecycle validation, and author critical documentation to support patient safety and product quality.

Qualifications

• Approximately 10+ years in qualification/validation within GMP environments.
• Expertise in moist heat sterilization and autoclave validation.
• Experience with VHP decontamination systems and controlled environments.
• Strong documentation, risk assessment and CAPA capabilities.

Responsibilities

• Act as SME for autoclave-based moist heat sterilization and VHP decontamination.
• Lead autoclave cycle development, qualification and validation activities.
• Plan IQ/OQ/PQ, maintain process definitions, and control strategies.
• Author and review validation protocols, reports, deviations, CAPAs, and change controls.

Skills

GMP knowledge

Sterilization

Validation

Autoclave

VHP decontamination

Regulatory compliance

Technical writing

Education

Bachelor's or Master's in Engineering/related field

Job description

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 RoleAs 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 AreWe 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.