Process Validation Engineer — GMP, CPV & Audits

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

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.