Senior Production Equipment Engineer - GMP, CAPEX & CQV

Lonza Group AG; Eyholz; Vor Ort; CHF 110.000 - 150.000; Vollzeit

Zusammenfassung

Lonza Group AG is seeking a Production Engineer to drive equipment lifecycle management and reliability for small utility and process devices at the BioAtrium site. The role emphasizes proactive maintenance to minimize downtime and ensure continuous biopharmaceutical production.

You will serve as SME on CAPEX projects, collaborating across Engineering, Operations, Quality and Validation. Candidates should have deep experience with CQV/Validation (IV, IQ/OQ/PQ) and risk assessments, and a strong

Qualifikationen

• 10+ years of professional engineering experience, incl. 3+ years in a cGMP pharmaceutical or biotechnology manufacturing environment.

Aufgaben

• Drive equipment lifecycle management and reliability for small utility and process devices at BioAtrium.
• Support continuous production by minimizing equipment downtime through preventive and corrective maintenance.
• Serve as SME on CAPEX projects, contributing to equipment design, selection, procurement, installation, and commissioning.
• Collaborate with Engineering, Operations, Quality, and Validation to maintain operational excellence.
• Troubleshoot complex equipment deviations using RCA and implement CAPAs.
• Author, review, and manage cGMP documentation, including SOPs, work instructions, change controls, and investigation reports.
• Represent the engineering department during audits and ensure audit readiness for small device systems.

Kenntnisse

Equipment lifecycle management

Reliability engineering

Maintenance optimization

CQV/Validation

Root Cause Analysis

GMP documentation

Audit readiness

English language

German language (advantage)

Ausbildung

Engineering degree (Mechanical/Process/Chemical)

Jobbeschreibung

Lonza Group AG is seeking a Production Engineer to drive equipment lifecycle management and reliability for small utility and process devices at the BioAtrium site. The role emphasizes proactive maintenance to minimize downtime and ensure continuous biopharmaceutical production.

You will serve as SME on CAPEX projects, collaborating across Engineering, Operations, Quality and Validation. Candidates should have deep experience with CQV/Validation (IV, IQ/OQ/PQ) and risk assessments, and a strong