Process Assessment and Validation Scientist II

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

Process Assessment and Validation Scientist II

Netherlands, Geleen

Process Assessment & Validation Scientist II
Location: Geleen, Netherlands
Minimum 4 days on Site.

Process Assessment & Validation Scientist II is involved in performing multiple assessments related to the implementation of a new process in the LNL facility, process validation activities and post-TT support of manufacturing processes.

What you will get:

• An agile dynamic working culture
• An inclusive and ethical workplace
• Compensation programs that recognize high performance

The full-time annual base pay for this position in The Netherlands is expected to range between EUR 48'000 MIN and EUR 67'200 MAX.Initialsalary placement within this range will bedeterminedbased on role‑related factors such as experience, qualifications, and expected contribution.

What you will do:

• Execute process assessment and validation activities in close collaboration with internal and external partners, ensuring delivery against agreed project timelines.
• Evaluate all process-related areas—including process design, Aseptic Process Simulation (APS), facility layout, equipment, and materials—from a GMP perspective to identify risks and define effective mitigation strategies.
• Monitor and trend performance data during and post-Technology Transfer (TT), assessing process capability and driving continuous process improvement initiatives.
• Lead root-cause investigations and technical troubleshooting for process-impacting deviations, acting as a Subject Matter Expert (SME).
• Champion and foster a culture of Operational Excellence and continuous improvement across all process activities.

What we are looking for:

• Deep understanding of CGT manufacturing technologies, process assessment, and field advances.
• Practical expertise in Good Manufacturing Practice (GMP) standards, aseptic processing, and Aseptic Process Simulation (APS).
• Proven ability to evaluate process, facility, equipment, and material risks, and implement robust mitigation plans.
• Track record of building strong working relationships with clients and internal cross-functional teams.
• Exceptional written and verbal communication skills, with a commitment to transparency and clarity.

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.

Reference: R79789

You will feel at home at Lonza if you:

• Take ownership, step forward, and enjoy meaningful responsibility
• Love solving problems and thrive in a complex, fast-moving environmentAre curious, always looking to learn and improve
• Work collaboratively, contributing to something bigger than yourself
• Are motivated to make a difference through work that impacts customers and their patients

Why Lonza:

We are a place of unique opportunity, where your ideas, expertise and ambition can make a real difference. Here, will have the freedom to grow, the support to succeed and the chance to contribute to work that matters.

We are the makers of the medicines of tomorrow.