On-Site CSV Validation Engineer for Biologics

Lonza; Lavamünd; Vor Ort; Vertraulich; Vollzeit

Benefits dieser Stelle

Agile culture

Inclusive workplace

Competitive salary

Lifestyle benefits

Zusammenfassung

Lonza is seeking a CSV Engineer (m/f/d) to lead validation of computerized systems on process engineering equipment. The role requires site-based work to ensure high-quality and safe manufacturing of medicines.

You will prepare commissioning and validation docs, supervise deviations, and coordinate with internal/external teams. English proficiency is required; German is a plus. Relocation assistance is available for eligible candidates and families.

Qualifikationen

• Bachelor/Master/Diploma from technical school or university in a technical field or equivalent experience.
• Significant experience in a regulated environment with CSV.
• Knowledge of industry tools such as KNEAT, COMOS, DMS, TrackWise, SAP is an advantage.
• Proficient in English; German language skills are advantageous.

Aufgaben

• Prepare commissioning and validation documents for new systems and supervise conversions and expansions.
• Supervise deviations, changes (GEP and GMP), and CAPAs with strict protocol adherence.
• Coordinate CSV executions with internal groups and external providers.
• Present CSV documents during audits and inspections.
• Schedule and report CSV activities and maintain records.
• Align CSV strategy with QA CSV for Biologics scope and contribute to document improvements.

Jobbeschreibung

Lonza is seeking a CSV Engineer (m/f/d) to lead validation of computerized systems on process engineering equipment. The role requires site-based work to ensure high-quality and safe manufacturing of medicines.

You will prepare commissioning and validation docs, supervise deviations, and coordinate with internal/external teams. English proficiency is required; German is a plus. Relocation assistance is available for eligible candidates and families.