Process Validation Scientist II – GMP, APS & TT Support

Lonza; Netherlands; On-site; Confidential; Full time

Benefits offered by this job

Agile dynamic working culture

Inclusive and ethical workplace

Compensation programs recognizing high

Benefits dependent on role and locale

Job summary

Lonza in Geleen, Netherlands seeks a Process Assessment & Validation Scientist II to perform assessments for new process implementation at the LNL facility, engage in process validation activities, and support post-TT manufacturing processes.

You will work with internal and external partners to deliver on project timelines, evaluate process design, APS, facility layout, equipment and materials from a GMP perspective, and drive continuous improvement through root-cause analyses and SME leadership.

Qualifications

• Deep understanding of CGT manufacturing technologies.
• Practical GMP standards knowledge and aseptic processing.
• Experience with Aseptic Process Simulation (APS).

Responsibilities

• Execute process assessment and validation activities with internal and external partners to meet project timelines.
• Evaluate process design, APS, facility layout, equipment, and materials from a GMP perspective to identify risks.
• Monitor performance data during and after Technology Transfer to assess capability and drive improvements.
• Lead root-cause investigations and provide technical troubleshooting as SME.
• Champion Operational Excellence and continuous improvement across all process activities.

Skills

CGT manufacturing

GMP standards

Aseptic processing

APS

Job description

Lonza in Geleen, Netherlands seeks a Process Assessment & Validation Scientist II to perform assessments for new process implementation at the LNL facility, engage in process validation activities, and support post-TT manufacturing processes.

You will work with internal and external partners to deliver on project timelines, evaluate process design, APS, facility layout, equipment and materials from a GMP perspective, and drive continuous improvement through root-cause analyses and SME leadership.