Process Validation Specialist — GMP, CPV & Regulatory Audits

Lonza Group Ltd.; Oberwallis; Vor Ort; CHF 110.000 - 150.000; Vollzeit

Zusammenfassung

Lonza Group Ltd. is seeking a Process Validation Specialist in Switzerland to lead validation strategies for commercial manufacturing. You will prepare and document validation protocols and reports, and support CPV and PQR throughout the product lifecycle.

The role requires a PhD or Master’s in Chemistry/Chemical Engineering, strong analytical skills, and fluent English (German a plus). You will interact with customers and work across multidisciplinary teams in a fast-paced environment.

Qualifikationen

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

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.
• Representing Process Validation 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

Process validation

GMP compliance

Cross-functional collaboration

Stakeholder management

Analytical skills

Ausbildung

PhD in Chemistry or related field

Master's in Chemistry or Chemical Engineering

Jobbeschreibung

Lonza Group Ltd. is seeking a Process Validation Specialist in Switzerland to lead validation strategies for commercial manufacturing. You will prepare and document validation protocols and reports, and support CPV and PQR throughout the product lifecycle.

The role requires a PhD or Master’s in Chemistry/Chemical Engineering, strong analytical skills, and fluent English (German a plus). You will interact with customers and work across multidisciplinary teams in a fast-paced environment.