Senior Sterilization Process Development Scientist/Engineer

<p><span><span>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.</span></span></p><p><span><span> </span></span></p><p><span><span>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.</span></span></p><p><span><span> </span></span></p><p><span><span>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.</span></span></p><p><b>Job Title: </b> Senior Sterilization Process Development Scientist/Engineer</p><p><b>Location: </b>Uppsala, Sweden, On-site</p><p></p><p><b>Job Description</b></p><p>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.</p><p>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.</p><p></p><p><b>Key responsibilities</b></p><ul><li>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.</li><li>Lead activities related to sterilization process development of injectable products under development, including work with regulatory submissions, design control, specifications, and risk assessments.</li><li>Represent the Process Science team in cross functional product development teams with other internal departments and external manufacturing partners.</li><li>Participate in key Product Science activities to assess impact of new regulations and implement appropriate changes</li><li>Keep up to date with innovations in aseptic and low bioburden processing, share and implement new technology in the organization.</li></ul><p></p><p> <b>Skills &amp; Qualifications </b></p><ul><li>Expertise in development and validation of Steam-In-Place and terminal sterilization for parenteral products using steam/moist heat</li><li>Experience with sterilization using irradiation methods is also desirable</li><li>Strong knowledge in microbiological controls and the use of biological indicators including risk assessment, validation and environmental monitoring techniques</li><li>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</li><li>Fluent in English, ability to work in Swedish is also desirable.</li><li>Strong communication skills, providing guidance and information to internal and external stakeholders and talking with regulatory bodies during inspections</li><li>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.</li></ul><p></p><p><b>What We Offer</b></p><p>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.</p><p><i>When you join us, you can expect:</i></p><p><b>Competitive Compensation &amp; Career Growth:</b> Attractive salary and benefits, continuous learning and clear opportunities for advancement. Work on innovative projects