Senior Sterilization Process Development Scientist/Engineer

Job Title: Senior Sterilization Process Development Scientist/Engineer

Location: Uppsala, Sweden, On-site

Job Description

Are you an experienced aseptic processing professional with experience in the sterilization of pharmaceuticals or medical devices? If so, this could be the role for you as we are now hiring a Senior Scientist/Engineer in our Injectable Development team.

Elevate your career by joining Galderma for a role that involves subject-matter expertise in the field of sterilization process development and process transfer to manufacturing facilities for both injectable medical devices and pharmaceuticals. As an integral part of the Product Science department, you will be highly involved in developing new products to further expand Galderma's portfolio and building our parenteral technology capabilities.

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.

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
• University degree in Chemical or Mechanical Engineering, Chemistry, Biochemistry, Biotechnology or similar technical field and 8 years experience in the pharmaceutical or medical device field.

What We Offer

At Galderma, we believe that our people are our most valuable asset and we are committed to creating an environment where you can thrive both professionally and personally.

When you join us, you can expect:

Competitive Compensation & Career Growth: Attractive salary and benefits, continuous learning and clear opportunities for advancement. Work on innovative projects that make a real difference in people's lives.

Global & Inclusive Culture: Collaborate across sites in North America, South America, and Europe in a diverse and inclusive environment that values teamwork and different perspectives.

Work-Life Balance & Wellbeing: Flexible working hours, wellness initiatives and on-site amenities including a fully equipped gym in a beautiful location by the river Fyris, just 10 minutes by bike from Uppsala city center.

Social Engagement & Team Spirit: Participate in an active leisure and sports club, enjoy quarterly town halls with fika, employee-led summer parties and celebrate key milestones such as Yellow Belt certifications together.

Next Steps

We welcome your application via our company website CAREERS | Galderma. Please apply as soon as possible as the selection process is ongoing and applications will be reviewed continuously.

If your profile matches our requirements, you will be invited to an initial virtual call with the recruiter.

The next step will be an interview with the hiring manager.

Then follows a panel discussion with the extended team.

Finally, a reference check is carried out before a possible offer is made.

We wish to inform applicants that Galderma can conduct pre-employment security checks for specific positions or activities. This security screening is performed by an external supplier after approval from applicants.