Aseptic Process Engineer - Compliance & Innovation

Johnson & Johnson Innovative Medicine; Schaffhausen; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

Johnson & Johnson is seeking a Compliance Engineer in Process Engineering at the Schaffhausen campus. The role focuses on supporting aseptic fill-finish operations, troubleshooting and documenting deviations, and driving change controls in a highly regulated environment.

You will work with cross-functional teams to evaluate new technologies, lead process improvements and ensure compliance with FDA/Annex 1 guidelines while contributing to a robust quality culture across the facility.

Qualifikationen

• Specifications & design of process equipment and systems in aseptic environment.
• Troubleshoot equipment failures and perform root-cause analysis with corrective actions.
• Support GMP-compliance of facility, utilities and process equipment.
• Write procedures, analyze data and report conclusions.
• Knowledge of HVAC, monitoring and aseptic qualifications.

Aufgaben

• Support the operation of process equipment and production in the Fill & Finish pilot plant.
• Troubleshooting, non-conformance management and documentation with QA.
• Manage change control systems and process improvements.
• Supervise the technical order system with maintenance and services.
• Train employees and evaluate new technologies for aseptic environment.
• Collaborate across engineering functions locally and globally.

Kenntnisse

Agile Decision Making

Coaching

Critical Thinking

Engineering

Problem Solving

Tools

SAP PLM

Jobbeschreibung

Johnson & Johnson is seeking a Compliance Engineer in Process Engineering at the Schaffhausen campus. The role focuses on supporting aseptic fill-finish operations, troubleshooting and documenting deviations, and driving change controls in a highly regulated environment.

You will work with cross-functional teams to evaluate new technologies, lead process improvements and ensure compliance with FDA/Annex 1 guidelines while contributing to a robust quality culture across the facility.