Senior Sterilization Engineer, Injectables - Galderma

Job Opportunity at Galderma

At Galderma, we inspire our teams with a shared belief in our bold ambition to become the world's leading dermatology company. As we expand operations at our state-of-the-art manufacturing facility in Uppsala, we're looking for driven, visionary people to join us.

To support this growth, we need skilled people who can build high-performing teams of specialists—teams that excel in a fast-paced environment where operational excellence is key.

About the Role

Galderma's process development team is growing and are now looking for an enthusiastic and driven subject-matter expert in the field of sterilization process development and process transfer to manufacturing facilities for both injectable medical devices and pharmaceuticals. You will work at the site in Uppsala but and be highly involved in developing new products to further expand Galderma's portfolio and building our parenteral technology capabilities.

This position is based in Uppsala, Sweden but Galderma offers a generous relocation support. However a requirement is that the candidate has a valid job permit for the European Union.

Key Responsibilities:

• Act as a steam sterilization Subject Matter Expert (SME) for projects and provide required experimental designs, data and author technical reports compliant with regulatory guidelines and industrial standards.
• Lead activities related to sterilization process development of injectable products under development, including work with regulatory submissions, design control, specifications, and risk assessments.
• Represent the Process Science team in cross functional product development teams with other internal departments and external manufacturing partners.
• Participate in key Product Science activities to assess impact of new regulations and implement appropriate changes
• Keep up to date with innovations in aseptic and low bioburden processing, share and implement new technology in the organization.

Your Profile

To succeed in this role, you need a BSc or MSc. degree in chemical/mechanical engineering, microbiology, or related discipline and 5+ years experience in the pharmaceutical or medical device field. We work in a fast-paced environment where proactivity and taking responsibility is of essence.

Skills & Qualifications

• Expertise in development and validation of Steam-In-Place and terminal sterilization for parenteral products using steam/moist heat
• Experience with sterilization using irradiation methods is also desirable
• Strong knowledge in microbiological controls and the use of biological indicators including risk assessment, validation and environmental monitoring techniques
• Knowledge of cGMP and Design Control in regulatory controlled work environments (e.g. ISO 13485, 21 CFR820, ICHQ8, 21CFR210/211, etc.) and experience preparing regulatory filings and supporting documentation
• Fluent in English, ability to work in Swedish is also desirable.
• Strong communication skills, providing guidance and information to internal and external stakeholders and talking with regulatory bodies during inspections

Why Join Galderma?

As part of the Process Development department, you will combine your technical expertise with a broad network of specialists, becoming a key contributor to the development of the next generation of injectable products. Galderma offers a dynamic environment where your knowledge will make a real impact and where you have room to grow professionally.

About Galderma

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 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.

Application

If you believe this could be the right career move for you, please send in an application as soon as possible. We evaluate applications continuously, so don't wait to apply. If you have any questions, please don't hesitate to reach out to Ellinor Crafoord.