Senior Process Compliance Engineer - Aseptic GMP

Johnson & Johnson AG; Schaffhausen; Vor Ort; CHF 140.000 - 190.000; Vollzeit

Zusammenfassung

Johnson & Johnson AG is seeking a Sr Compliance Engineer to support process engineering, qualification, and validation in aseptic environments at Schaffhausen. You will work on process equipment, utilities, and computerized systems in CM&T F2P2, ensuring GMP compliance and handling change control.

The role requires cross-functional collaboration, leadership potential, and experience in design, qualification, and optimization of aseptic fill-finish processes.

Qualifikationen

• Required: experience in process engineering in pharmaceutical/chemical environment.
• Strong design and specification skills for aseptic process equipment and systems.
• Experience with GMP compliance, validation, qualification and change control.

Aufgaben

• Provide engineering and qualification support for process equipment, utilities, facilities and computerized systems in CM&T F2P2.
• Support operation of process equipment and production at technical level in pilot plant.
• Troubleshoot, document non-conformances, and manage change control processes.
• Supervise technical order system with mechanics and services.
• Train employees and evaluate/qualify new technology platforms in aseptic environment.
• Collaborate across engineering functions locally and globally.

Kenntnisse

Agile Decision Making

Coaching

Critical Thinking

Emerging Technologies

Engineering

Problem Solving

Process Control

Process Engineering

Process Improvements

Product Costing

Product Improvements

Research and Development

SAP Product Lifecycle Management

Situational Awareness

Technical Research

Technical Writing

Technologically Savvy

Vendor Selection

Tools

SAP Product Lifecycle Management

Jobbeschreibung

Johnson & Johnson AG is seeking a Sr Compliance Engineer to support process engineering, qualification, and validation in aseptic environments at Schaffhausen. You will work on process equipment, utilities, and computerized systems in CM&T F2P2, ensuring GMP compliance and handling change control.

The role requires cross-functional collaboration, leadership potential, and experience in design, qualification, and optimization of aseptic fill-finish processes.