Process Validation Scientist II: GMP & Aseptic Excellence

Lonza Group Ltd.; Geleen; Presencial; EUR 48.000 - 67.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Agile culture

Inclusive workplace

Performance rewards

Benefits by role/location

Benefits portal access

Descripción de la vacante

Lonza in Geleen, Netherlands is seeking a Process Assessment & Validation Scientist II on-site to drive assessments for new processes, validation activities, and post-TT support of manufacturing processes.

You will evaluate design, APS, GMP compliance, and monitor data during TT, leading improvements and investigations with cross-functional teams. This role requires CGT know-how and strong communication.

Formación

• Deep understanding of CGT manufacturing technologies and process assessment.
• GMP, aseptic processing, and APS expertise.
• Ability to assess risks in process, facility, equipment, and materials and implement mitigation plans.
• Strong relationships with clients and cross-functional teams.
• Excellent written and verbal communication for transparency and clarity.

Responsabilidades

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

Conocimientos

CGT manufacturing knowledge

GMP experience

Aseptic processing

APS (Aseptic Process Simulation)

Process assessment

Communication skills

Descripción del empleo

Lonza in Geleen, Netherlands is seeking a Process Assessment & Validation Scientist II on-site to drive assessments for new processes, validation activities, and post-TT support of manufacturing processes.

You will evaluate design, APS, GMP compliance, and monitor data during TT, leading improvements and investigations with cross-functional teams. This role requires CGT know-how and strong communication.