Bioprocess Deviation Investigator - GMP & CAPA Lead

Lonza; Oberwallis; Vor Ort; Vertraulich; Vollzeit

Benefits dieser Stelle

Agile culture

Inclusive workplace

Performance rewards

Cross-functional teams

Professional development

Location-based benefits

Zusammenfassung

Lonza Visp in Switzerland is seeking a Bioprocess Engineer for Deviation Investigation 80%-100% (m/w/d). You will lead GMP deviation investigations, perform root cause analyses, and define CAPAs within Module L, collaborating with Operations, QA, MSAT, QC, and Engineering to ensure compliance and product quality.

The role is on-site at Visp, offering exposure to complex GMP investigations, inspection readiness, and continuous improvement in a world-class biopharmaceutical manufacturing

Qualifikationen

• Experience in biotech or GMP-regulated manufacturing.
• Proven ability to lead or support deviation investigations and CAPA.
• Understanding of GMP, cleaning validation, and qualification activities.
• Strong data analysis and evidence-based conclusions.
• Excellent cross-functional collaboration and communication.

Aufgaben

• Lead GMP deviation investigations for manufacturing modules.
• Perform structured fact-finding, root cause analysis, and CAPA assessments.
• Collaborate with Operations, QA, MSAT, QC, Engineering to define CAPAs.
• Draft, review, and close deviation records within timelines.
• Maintain inspection-ready, GMP-compliant investigation records.
• Support audits and regulatory inspections with evidence and CAPA strategies.
• Contribute to deviation reduction and continuous improvement.

Kenntnisse

GMP experience

Deviation investigations

CAPA management

Root cause analysis

Stakeholder management

Scientific communication

Ausbildung

Biotech/Bioprocess/Chemical Eng degree

Jobbeschreibung

Lonza Visp in Switzerland is seeking a Bioprocess Engineer for Deviation Investigation 80%-100% (m/w/d). You will lead GMP deviation investigations, perform root cause analyses, and define CAPAs within Module L, collaborating with Operations, QA, MSAT, QC, and Engineering to ensure compliance and product quality.

The role is on-site at Visp, offering exposure to complex GMP investigations, inspection readiness, and continuous improvement in a world-class biopharmaceutical manufacturing