Bioprocess Deviation Lead - GMP Investigation Expert

Lonza; Schweiz; Hybrid; Vertraulich; Vollzeit

Zusammenfassung

Lonza in Visp, Switzerland, seeks a Bioprocess Engineer, Deviation Investigation 80%-100% (m/w/d) to lead GMP deviation investigations on site. You will collaborate with Operations, QA, MSAT, QC and Engineering to ensure product quality and regulatory compliance in a high‑regulation biopharma environment.

Responsibilities include structured fact finding, root‑cause analysis, CAPA development, and drafting investigation records; you will support audits and inspections and help standardize

Qualifikationen

• Experience in GMP-regulated manufacturing environments.
• Experience leading or supporting deviation investigations and CAPA processes.
• Strong understanding of GMP requirements and quality systems.

Aufgaben

• Lead GMP deviation investigations for manufacturing and related activities.
• Conduct structured fact finding, event reconstruction, root cause analysis and impact assessments.
• Draft, review, and close deviation records with CAPA actions.
• Support internal audits, customer inspections, and regulatory inspections with investigation outcomes.

Jobbeschreibung

Lonza in Visp, Switzerland, seeks a Bioprocess Engineer, Deviation Investigation 80%-100% (m/w/d) to lead GMP deviation investigations on site. You will collaborate with Operations, QA, MSAT, QC and Engineering to ensure product quality and regulatory compliance in a high‑regulation biopharma environment.

Responsibilities include structured fact finding, root‑cause analysis, CAPA development, and drafting investigation records; you will support audits and inspections and help standardize