Manufacturing Scientist, Assembly & Packaging

Manufacturing Scientist, Assembly & Packaging

Galderma

Uppsala, Sweden

We are now looking for a passionate and hands-on Process Development Engineer to join our Assembly & Packaging team within Manufacturing Science and Technology (MSAT) in Uppsala.

In this role, you will play a key part in technology transfer, process validation, and continuous improvement activities for our world-leading biopharmaceutical and medical device manufacturing operations.

About the Role

As a Process Development Engineer, you will act as a subject matter expert (SME) for assembly and packaging processes within commercial manufacturing.

You will support new product introductions (NPI), drive tech transfer projects, and ensure robust and compliant manufacturing processes through validation, risk management, and investigation work.

Key responsibilities include:

• Lead and support technology transfer activities including comparability assessments and process performance qualification.
• Acting as a process owner for assembly and packaging, providing technical support to production.
• Lead investigations and problem-solving activities including root cause analyses, and corrective and preventive actions (CAPA).
• Supporting process validation, change control, and risk management activities.
• Review and contribute to GMP documentation, including SOPs, change controls, and qualification protocols
• Preparing and reviewing technical and validation documentation in line with GMP and regulatory requirements.
• Collaborating cross-functionally with Production, QA, RA, and R&D to ensure alignment, efficiency, and quality.
• Driving continuous improvement, cost-reduction initiatives, and operational excellence within manufacturing.

Are You the One We are Looking For?

• You are a motivated engineer with a strong technical foundation and a passion for biopharma or medical device manufacturing.
• You thrive in a GMP-regulated environment, take ownership of your work, and enjoy solving complex technical challenges in collaboration with others.
• You bring curiosity, initiative, and structure - with the confidence to lead projects and the humility to work as part of a team.

Skills & Qualifications

Must-Haves (Knock-Out Criteria):

• Degree: BSc or MSc in Life sciences, Engineering or related scientific discipline.
• Industry Experience: Minimum 3-5 years of hands-on experience in biopharmaceutical or medical device manufacturing within assembly and/or packaging.
• Tech Transfer: Proven experience transferring processes from development to commercial manufacturing or between GMP production sites.
• Investigation Skills: Solid experience in deviation handling, root cause analysis, and CAPA implementation; capable of performing technical and impact assessments in support of commercial operations.
• GMP Knowledge: Strong understanding of regulatory frameworks, cGMP compliance, and manufacturing documentation standards.
• Strong knowledge of EU/US GMP guidelines and regulatory standards.
• Strategic and analytical thinking with the ability to assess risks and make balanced decisions.

Strong Nice-to-Haves:

• Experience with Lean or Six Sigma methodologies.
• Background in process validation, protocol writing, and reporting.
• Exposure to cross-functional collaboration (QA, RA, Production, R&D).
• Strong documentation and analytical skills, including statistical process monitoring.
• Strong technical writing and communication skills.
• Familiarity with CPV (Continued Process Verification), FMEA, and risk assessments.