Manufacturing Scientist / MSAT Engineer (M/F) - 100 %

• 27 August 2026
• 100%
• Indefinite duration
• Fribourg
• Log in to see the jobup.ch salary estimate

On behalf of one of our clients, an international company specialized in in vitro diagnostics and based in the canton of Fribourg, we are looking for a Manufacturing Scientist / MSAT Engineer at 100 %.

Within the Bio-Engineering team, you will be the technical referent for the manufacturing processes of in vitro diagnostic products intended for blood transfusion.

At the interface between production, quality assurance, and regulatory affairs, your mission will be to guarantee the robustness, compliance, and control of processes, in compliance with IVDR, ISO 13485, and GMP requirements.

Manufacturing Scientist / MSAT Engineer (M/F) - 100 %

Your responsibilities

• Lead technical investigations related to non-conformities using structured root cause analysis methodologies: Ishikawa, 5 Whys, FMEA, etc.
• Define and implement appropriate corrective, preventive, and containment actions.
• Manage CAPAs, from their definition to the verification of their effectiveness, in collaboration with the various teams concerned.
• Write, review, and approve change requests within the framework of the Change Control process.
• Evaluate the impact of changes on processes, validation activities, and regulatory requirements.
• Lead projects related to manufacturing processes, ensuring the management of scope, deadlines, risks, and different stakeholders.
• Maintain deep knowledge of processes and their control strategy throughout the product life cycle.
• Identify the main sources of variability as well as the root causes of failures.
• Perform investigations and practical laboratory tests in order to characterize problems, test hypotheses, and confirm identified causes.
• Write technical documentation: sampling plans, procedures, risk analyses, protocols, and technical reports.
• Present and synthesize scientific, technical, and quality issues to various interlocutors to facilitate decision-making.

Your profile

• Higher degree in life sciences, biology, biochemistry, chemistry or in an equivalent field, at engineer or Master's level.
• Minimum 3 to 5 years of experience in the pharmaceutical industry or in vitro diagnostics.
• Practical experience with biology, biochemistry and/or immunology techniques as well as automated systems.
• Experience or knowledge in immunohematology is an asset.
• Solid scientific background and excellent analytical skills.
• Mastery of investigation, root cause analysis, and risk assessment methodologies.
• Technical and practical laboratory skills, as the position includes experimental bench work activities.
• Good knowledge of the regulatory environment applicable to in vitro diagnostic devices: IVDR, ISO 13485 and GMP.
• Ability to evaluate the regulatory impact of changes made to processes.
• Structured, methodical, and rigorous personality, with solid skills in project management, communication, and synthesis.
• Fluent command of French and English, knowledge of German is an advantage.