Senior Process Engineer Assembly

Galderma, with a science-driven portfolio across Aesthetics, Skincare, and Therapeutics, has been advancing dermatology since 1981. We're expanding our site in Uppsala with a new state-of-the-art manufacturing facility to meet growing demand for our medicinal products. Join us in shaping the future of dermatology

We're looking for driven, collaborative individuals who embrace learning and bring positive energy to join our inclusive, growth-oriented culture. We are now recruiting a Senior Process Engineer Assembly & Packaging department.

The roles act as subject matter expert (SME) responsible for new product implementation (NPI) into a manufacturing facility, and for set up and support in productions processes injector assembly, visual inspection and packaging.

You will be part of a team and collaborate with cross-functional teams, including production, quality assurance, regulatory affairs, and process development, to ensure thorough investigation and perform risk assessments.

Key responsibilities:

• Develop NPI strategy and support all aspects of process validation, including writing process validation documentation, executing process validation, performing process data reviews, investigations, risk management, and change implementation.
• Serve as SME representing MS&T in Technology Transfer projects.
• Lead and participate in investigations of deviations, incidents, and anomalies within the manufacturing process. 
• Provide SME assessments in investigations and change controls as required. Prepare detailed investigation reports, conveying findings and recommendations to management and relevant stakeholders.
• Maintain comprehensive records of investigations, findings, actions taken, and recommendations, ensuring compliance with regulatory and quality standards
• Write technical manufacturing documentation and dossier sections and provide responses to regulatory authorities as needed.

The positions are permanent with a 6-month probation period, based in Uppsala, and the employment contract will be directly with Galderma.

To succeed in this role, you need a BSc or MSc in a relevant scientific or engineering field and solid experience from relevant work. We work in a fast-paced environment where proactivity and taking responsibility is of essence.

Skills & Qualifications

• Bachelor's or master's degree in a relevant scientific or engineering field
• Approximately 6 years of experience in a biopharmaceutical or medical device. 
• Knowledge of regulatory requirements related to investigations and cGMP
• Strong knowledge of investigative methodologies and root cause analysis techniques.
• Experience from either process validation for manufacturing steps such as injector assembly, visual inspection and packaging.
• Proficient in English, with Swedish as a plus.

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.

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 ,