Process Validation Engineer — GMP, Audits & Customer Impact

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

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.