Project Engineer – GMP Projects (Visp, Switzerland)

About the role

We are seeking a Project Engineer to lead GMP‑compliant projects at our Visp facility. You will be responsible for defining technical requirements, guiding mechanical adaptations, and ensuring successful qualification of equipment and processes.

Key responsibilities

• Define technical requirements and success criteria aligned with GMP standards, operational goals, and compliance expectations.
• Develop a comprehensive project roadmap from conceptual design through performance qualification (PQ).
• Act as the primary technical point of contact, ensuring mechanical adaptations meet specifications.
• Provide guidance to production staff implementing operational improvements.
• Ensure all activities comply with GMP regulations and internal quality standards.
• Manage GMP change control processes, including preparation, review, and approval of Technical Change Requests and Change Records.
• Coordinate with operations, maintenance, engineering, and quality teams for seamless integration of adaptations.
• Monitor project progress, conduct risk assessments, and report regularly to stakeholders.
• Lead equipment commissioning, installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) activities.

Required profile

• Bachelor’s or Master’s degree in Biochemical Engineering, Mechanical Engineering, Life Sciences or a related field.
• Minimum 5 years experience in biopharmaceutical manufacturing with a focus on technical project management or operational excellence.
• Proven experience on GMP‑compliant projects, including change management and qualification activities.
• Hands‑on experience in commissioning, qualification, and validation (CQV) of equipment and processes.
• Strong knowledge of GMP regulations and biopharmaceutical manufacturing processes.
• Proficiency with project management tools and methodologies.

Required skills

• CQV (Commissioning, Qualification, Validation) experience in a GMP environment.
• Project Engineering expertise.
• GMP compliance knowledge.
• Project Management tools proficiency.
• Commissioning of equipment.
• Qualification and validation of processes.