Senior CSV Lead: MES & GxP Compliance (Site-Based)

Lonza; Stein; Vor Ort; Vertraulich; Vollzeit

Benefits dieser Stelle

Agile career

Inclusive workplace

Competitive hourly rate

Zusammenfassung

Lonza in Stein, Switzerland is seeking a Senior QA Expert CSV to lead quality oversight across major CAPEX projects, ensuring MES/Automation systems meet GxP and regulatory requirements.

You will review validation lifecycle docs (FRS, IQ, OQ, PQ), manage MODA integration deliverables, Change Controls, Deviations, and collaborate across Automation, IT, Manufacturing and Engineering to keep systems compliant. Excellent English; German a plus. Site-based role with competitive compensation.

Qualifikationen

• Proven experience in Computerized Systems Validation (CSV) in biopharma.
• Strong knowledge of GAMP 5 and data integrity.
• Experience reviewing FRS, IQ/OQ/PQ documents.
• Excellent written and verbal communication.

Aufgaben

• Serve as the QA authority ensuring CSV meets GxP across major CAPEX projects.
• Perform QA review and approval of validation lifecycle documentation (FRS, IQ, OQ, PQ).
• Oversee and approve MODA integration deliverables and Automation Change Controls (ACCs).
• Assess and approve Change Controls, Deviations, and Incident Reports relating to automated systems and data integrity.
• Collaborate closely with cross‑functional teams across Automation, IT, Manufacturing, and Engineering to maintain systems in a compliant state.
• Provide expert CSV and data integrity guidance to project leads and operational partners throughout the project lifecycle.
• Support continuous improvement of validation standards and compliance frameworks within the site.

Kenntnisse

CSV expertise

GxP compliance

Validation oversight

Stakeholder collaboration

Ausbildung

Bachelor's or Master's in Engineering, Computer Science, Life Sciences or related field

Jobbeschreibung

Lonza in Stein, Switzerland is seeking a Senior QA Expert CSV to lead quality oversight across major CAPEX projects, ensuring MES/Automation systems meet GxP and regulatory requirements.

You will review validation lifecycle docs (FRS, IQ, OQ, PQ), manage MODA integration deliverables, Change Controls, Deviations, and collaborate across Automation, IT, Manufacturing and Engineering to keep systems compliant. Excellent English; German a plus. Site-based role with competitive compensation.