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

On behalf of one of our clients, an international company specialised 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 reference 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 ensure the robustness, compliance and control of processes, in accordance with the requirements of IVDR, ISO 13485 and GMP.

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 CAPA from definition to verification of effectiveness, in collaboration with the various teams involved.
• Write, review and approve change requests within the Change Control process.
• Assess the impact of changes on processes, validation activities and regulatory requirements.
• Lead projects related to manufacturing processes, ensuring scope, deadlines, risks and stakeholder management.
• Maintain in-depth knowledge of processes and their control strategy throughout the product lifecycle.
• Identify main sources of variability as well as root causes of failures.
• Conduct investigations and practical laboratory tests to characterise issues, test hypotheses and confirm identified causes.
• Write technical documentation: sampling plans, procedures, risk analyses, protocols and technical reports.
• Present and summarise scientific, technical and quality issues to various stakeholders to facilitate decision-making.

Your profile

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