Process Validation Specialist 60-100%

Lonza Group; Schweiz; Remote; CHF 120.000 - 170.000; Vollzeit

Zusammenfassung

Lonza Group is seeking a Process Validation Specialist to lead validation strategies for commercial manufacturing and to collaborate across functions. You will prepare, execute and document protocols, supporting CPV and PQR throughout the lifecycle.

The role requires a PhD or Master’s in a related field, GMP experience, and strong analytical, communication, and stakeholder-management skills to work across complex projects in a global life sciences environment.

Qualifikationen

• PhD or Master’s degree in Chemistry, Chemical Engineering, or related field.
• GMP experience is highly preferred.
• Strong analytical and problem-solving abilities.

Aufgaben

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

Kenntnisse

Analytical skills

Problem-solving

Multidisciplinary teamwork

Communication skills

Stakeholder management

Prioritization

English fluent

German language helpful

Ausbildung

PhD or Master’s in Chemistry/Chemical Engineering

Jobbeschreibung

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.

• Take ownership, step forward, and enjoy meaningful responsibility
• Love solving problems and thrive in a complex, fast-moving environment
• Are 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.