IVD Manufacturing Scientist: Process Excellence & CAPA

Bio-Rad Laboratories; Grissach; Vor Ort; CHF 110.000 - 150.000; Vollzeit

Benefits dieser Stelle

Competitive salary

Annual bonus and salary review

Training and LinkedIn Learning access

Zusammenfassung

Bio‑Rad in Cressier is seeking a Manufacturing Scientist (m/f/d) to own manufacturing processes behind IVD blood‑transfusion products. The role sits at the interface of manufacturing, quality and regulatory (IVDR, ISO 13485, GMP) to keep processes robust, compliant and under control.

You will investigate non-conformities, drive CAPAs, lead projects, and assess regulatory impacts of changes across the product lifecycle with a strong emphasis on documentation and cross‑functional collaboration.

Qualifikationen

• Degree in Life Sciences (Biology, Biochemistry, Chemistry or equivalent).
• 3–5 years in diagnostics or pharmaceutical industry with hands‑on biology/biochemistry/immunology and automation.
• Strong scientific and analytical background with root‑cause methods.
• Solid understanding of IVD regulatory framework (IVDR, ISO 13485, GMP) and regulatory impact assessment.
• Fluent in French and English; German is a plus.

Aufgaben

• Manage non-conformities and lead technical investigations using structured root-cause methods.
• Drive CAPAs from definition to effectiveness check within cross-functional teams.
• Master change control: author, review and approve change requests and assess regulatory impact.
• Lead manufacturing projects: manage scope, timelines, risk and stakeholders.
• Own process knowledge across the product lifecycle and identify sources of variability and root causes of failures.
• Author technical documentation: sampling plans, SOPs, risk assessments, protocols and technical reports.
• Communicate complex technical and quality issues clearly to diverse audiences.

Kenntnisse

Life sciences background

Root-cause analysis

Project management

Bench work

Analytical thinking

French language

English language

German language (plus)

Ausbildung

Dipl. Ing./M.Sc. Life Sciences

Tools

Automation techniques

Quality systems (IVDR/ISO 13485)

Jobbeschreibung

Bio‑Rad in Cressier is seeking a Manufacturing Scientist (m/f/d) to own manufacturing processes behind IVD blood‑transfusion products. The role sits at the interface of manufacturing, quality and regulatory (IVDR, ISO 13485, GMP) to keep processes robust, compliant and under control.

You will investigate non-conformities, drive CAPAs, lead projects, and assess regulatory impacts of changes across the product lifecycle with a strong emphasis on documentation and cross‑functional collaboration.