Lead Production Equipment Engineer – Biopharma (Site)

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

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