Production Engineer Small Devices

Lonza; Oberwallis; Vor Ort; Vertraulich; Vollzeit

Zusammenfassung

Lonza in Visp, Switzerland seeks an experienced engineer to ensure the reliability of small manufacturing equipment at the BioAtrium site on a 6-month contract. The role emphasizes proactive maintenance, CAPEX project SME duties, and close collaboration with Engineering, Operations, Quality and Validation to uphold high GMP standards.

The ideal candidate has at least 10 years in engineering, with 3+ years in a cGMP pharma/biotech environment, strong RCA skills, and fluency in English (German a

Qualifikationen

• Minimum 10 years of professional engineering experience, with at least 3 years in a cGMP pharmaceutical or biotechnology manufacturing environment.
• Expertise in equipment lifecycle management and maintenance optimization.
• Hands-on experience with equipment commissioning, qualification, and validation (CQV/Validation: IV, IQ/OQ/PQ) and risk assessments.
• Demonstrated RCA capabilities; formal RCA certification is an advantage.
• Strong track record of authoring GMP quality records (deviations, CAPAs, change controls).
• Professional fluency in English; working knowledge of German is an advantage.

Aufgaben

• Drive equipment lifecycle management and reliability for small utility and process devices across the BioAtrium site.
• Support the continuous production of biopharmaceuticals by minimizing equipment downtime through proactive preventive and corrective maintenance.
• Serve as the Subject Matter Expert (SME) on CAPEX projects, contributing to equipment design, selection, procurement, installation, and commissioning.
• Collaborate with cross-functional teams including Engineering, Operations, Quality and Validation to maintain operational excellence.
• Troubleshoot complex equipment deviations using structured Root Cause Analysis (RCA) and implement effective CAPAs.
• Author, review, and manage critical cGMP documentation, including SOPs, work instructions, change controls, and investigation reports.
• Represent the engineering department during internal and external audits, ensuring complete audit readiness for small device systems.

Kenntnisse

Lifecycle management

Reliability engineering

CQV/Validation

Root Cause Analysis

GMP documentation

Audit readiness

English fluency

German knowledge

Ausbildung

Engineering degree

Jobbeschreibung

Ensure the operational readiness and reliability of vital small manufacturing equipment at our BioAtrium facility in Visp, directly supporting the delivery of life-changing biopharmaceuticals. This is a fully site‑based 6-month contract role.

Fully site‑based roles

This is a fully site‑based role. Working together in person supports close, real‑time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards.

What you will get:

• An agile career and dynamic working culture.
• An inclusive and ethical workplace.

What you will do:

• Drive equipment lifecycle management and reliability for small utility and process devices across the BioAtrium site.
• Support the continuous production of biopharmaceuticals by minimizing equipment downtime through proactive preventive and corrective maintenance.
• Serve as the Subject Matter Expert (SME) on CAPEX projects, contributing to equipment design, selection, procurement, installation, and commissioning.
• Collaborate closely with cross-functional teams including Engineering, Operations, Quality, and Validation to maintain operational excellence.
• Troubleshoot complex equipment deviations using structured Root Cause Analysis (RCA) and implement effective CAPAs.
• Author, review, and manage critical cGMP documentation, including SOPs, work instructions, change controls, and investigation reports.
• Represent the engineering department during internal and external audits, ensuring complete audit readiness for small device systems.

What we are looking for:

• Minimum 10 years of professional engineering experience, with at least 3 years in a cGMP pharmaceutical or biotechnology manufacturing environment.
• Proven expertise in equipment lifecycle management, reliability engineering, and maintenance optimization.
• Hands‑on experience with equipment commissioning, qualification, and validation (CQV/Validation: IV, IQ/OQ/PQ) and risk assessments.
• Demonstrated track record in technical troubleshooting and Root Cause Analysis (RCA); formal RCA certification is an advantage.
• Strong proficiency in authoring and managing GMP quality records (deviations, CAPAs, change controls).
• Professional fluency in English (written and spoken); working knowledge of German is an advantage.
• Degree in Engineering (Mechanical, Process, Chemical, or related technical discipline).

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table.

At Lonza, we value diversity and are committed to creating an inclusive environment.