Process Assessment & Validation Scientist II – GMP Expert

Lonza; Geleen; On-site; EUR 48,000 - 67,000; Full time

Benefits offered by this job

Agile culture

Inclusive workplace

Competitive compensation

Job summary

Lonza in Geleen, Netherlands, seeks a Process Assessment & Validation Scientist II to drive process validation activities for CGT manufacturing. This role involves collaborations with internal and external partners, ensuring GMP-compliant designs and robust risk mitigation throughout the process lifecycle.

You will monitor TT-related data, drive continuous improvement, and lead investigations into deviations, contributing to an inclusive and high-performance manufacturing culture at Lonza.

Qualifications

• Deep understanding of CGT manufacturing technologies and process assessment.
• Strong knowledge of GMP standards and aseptic processing.
• Experience with risk assessment and mitigation planning in manufacturing.
• Proven ability to collaborate with internal and external partners to meet timelines.
• Excellent written and verbal communication for cross-functional teams.

Responsibilities

• Execute process assessment and validation activities with internal/external partners, ensuring timely delivery.
• Evaluate process-related areas from a GMP perspective to identify risks and mitigation strategies.
• Monitor and trend performance data during and after Technology Transfer (TT).
• Lead root-cause investigations and troubleshoot process-impacting deviations as SME.
• Champion Operational Excellence and continuous improvement across process activities.

Skills

CGT manufacturing

GMP compliance

Aseptic processing

Aseptic Process Simulation

Cross-functional collaboration

Job description

Lonza in Geleen, Netherlands, seeks a Process Assessment & Validation Scientist II to drive process validation activities for CGT manufacturing. This role involves collaborations with internal and external partners, ensuring GMP-compliant designs and robust risk mitigation throughout the process lifecycle.

You will monitor TT-related data, drive continuous improvement, and lead investigations into deviations, contributing to an inclusive and high-performance manufacturing culture at Lonza.