Process Assessment and Validation Scientist II

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

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
• A variety of benefits dependent on role and location. The full list of our global benefits can be also found on https://www.lonza.com/careers/benefits

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.