Process Validation Specialist 60-100%

Lonza; Schweiz; Vor Ort; Vertraulich; Vollzeit

Zusammenfassung

Lonza in Switzerland seeks a Process Validation Specialist to lead validation for commercial manufacturing, supporting CPV and PQR across the product lifecycle.

The role requires a PhD or Master in chemistry/chemical engineering, GMP experience, and strong analytical and communication skills. English is essential; German is a plus. You will engage in customer meetings and audits while ensuring compliance with global regulatory guidelines.

Qualifikationen

• PhD or Master's degree in Chemistry, Chemical Engineering, or a related scientific discipline.
• Experience in pharmaceutical or chemical manufacturing; GMP experience is highly preferred.
• Strong analytical and problem-solving skills.
• Ability to work effectively in multidisciplinary teams.
• Fluent English language skills; German is a plus.
• Strong communication and stakeholder management skills.
• Ability to manage multiple priorities in a fast-paced project environment.

Aufgaben

• Developing process validation strategies for commercial manufacturing processes.
• Preparing, executing, and documenting validation protocols and reports.
• Supporting Continued Process Verification (CPV) and Product Quality Reviews (PQR) throughout the product lifecycle.
• Assessing the validation impact of deviations, investigations, and change requests.
• Acting as the Process Validation representative in customer meetings and cross-functional projects.
• Serving as the subject matter expert during customer audits and regulatory inspections.
• Ensuring compliance with internal procedures, cGMP requirements, and relevant regulatory guidelines (ICH, FDA, EMA, PIC/S).

Kenntnisse

Process validation

GMP experience

Analytical skills

Cross-functional

Stakeholder management

Multidisciplinary teams

English fluency

German language a plus

Ausbildung

PhD or Master in Chemistry / Chemical Engineering

Jobbeschreibung

Process Validation Specialist, 60-100% Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that's the kind of work we want to be part of. The position as Process Validation Specialist is ideal for a scientist or engineer who enjoys combining technical expertise, GMP compliance, cross-functional collaboration, and customer interaction. The role offers significant ownership and visibility across a diverse portfolio of commercial manufacturing projects.

Key responsibilities:

• Developing process validation strategies for commercial manufacturing processes.
• Preparing, executing, and documenting validation protocols and reports.
• Supporting Continued Process Verification (CPV) and Product Quality Reviews (PQR) throughout the product lifecycle.
• Assessing the validation impact of deviations, investigations, and change requests.
• Acting as the Process Validation representative in customer meetings and cross-functional projects.
• Serving as the subject matter expert during customer audits and regulatory inspections.
• Ensuring compliance with internal procedures, cGMP requirements, and relevant regulatory guidelines (ICH, FDA, EMA, PIC/S).

Key requirements:

• PhD or Master's degree in Chemistry, Chemical Engineering, or a related scientific discipline.
• Experience in pharmaceutical or chemical manufacturing; GMP experience is highly preferred.
• Strong analytical and problem-solving skills.
• Ability to work effectively in multidisciplinary teams.
• Strong communication and stakeholder management skills.
• Ability to manage multiple priorities in a fast-paced project environment.
• Fluent English language skills, both written and spoken. German is a plus.

Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.