Process Validation Scientist II: GMP & Aseptic Expert (Onsite)

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

Benefits offered by this job

Inclusive workplace

Benefits dependent on role and locale

Performance-based compensation

Job summary

Lonza in Geleen, Netherlands, seeks a Process Assessment & Validation Scientist II to drive the implementation of new processes at the LNL facility. The role covers multiple assessments, process validation activities, and post-transfer support for manufacturing processes, with at least four days on site.

You will collaborate with internal and external partners to ensure timely delivery, evaluate GMP aspects including APS, monitor post-transfer performance, lead root-cause investigations, and

Qualifications

• Deep understanding of CGT manufacturing technologies and field advances.
• Practical expertise in GMP, aseptic processing, and APS.
• Proven ability to evaluate process, facility, equipment, and material risks and implement mitigation plans.
• Track record of building strong working relationships with clients and cross-functional teams.
• Excellent written and verbal communication, with clarity and transparency.

Responsibilities

• Execute process assessment and validation activities with internal/external partners to meet project timelines.
• Evaluate process design, APS, facility layout, equipment, and materials from a GMP perspective to identify risks and mitigation strategies.
• Monitor and trend performance data during and after TT, assessing process capability and driving continuous improvement.
• Lead root-cause investigations and technical troubleshooting for process-impacting deviations as SME.
• Champion Operational Excellence and continuous improvement across all process activities.

Skills

CGT manufacturing

GMP compliance

Aseptic processing

APS

Risk assessment

Client relationship building

Job description

Lonza in Geleen, Netherlands, seeks a Process Assessment & Validation Scientist II to drive the implementation of new processes at the LNL facility. The role covers multiple assessments, process validation activities, and post-transfer support for manufacturing processes, with at least four days on site.

You will collaborate with internal and external partners to ensure timely delivery, evaluate GMP aspects including APS, monitor post-transfer performance, lead root-cause investigations, and