Senior Compliance Engineer: Aseptic Process Innovation

Biopharma Asia; Schaffhausen; Hybrid; CHF 120,000 - 170,000; Full time

Job summary

Johnson & Johnson is seeking a Senior Compliance Engineer in Process Engineering in Schaffhausen, Switzerland. The role focuses on engineering, qualification, validation support, and aseptic process improvements to ensure regulatory compliance and product quality.

You will lead troubleshooting, support technology implementations, and collaborate with QA, production, and suppliers to drive efficiency and safety in aseptic manufacturing.

Qualifications

• Proven experience specifying and designing process equipment and systems for aseptic environments.
• Strong troubleshooting skills with root cause analysis and corrective actions.
• Experience with GMP compliance of facilities, utilities and equipment.
• Experience writing procedures and protocols, analyzing data and producing technical reports.
• Knowledge of HVAC systems and aseptic fill/sterile manufacturing is an advantage.

Responsibilities

• Engineering and qualification of process equipment, utilities and facilities.
• Support validation on process equipment and computerized systems.
• Provide technical support for operation of process equipment and production.
• Lead troubleshooting, corrective actions and documentation for issues and NCs.
• Manage changes and optimization through change control.
• Oversee the technical work order system with maintenance services.
• Deliver training to operators and staff on system/process levels.
• Support evaluation and implementation of new technologies in aseptic environments.
• Collaborate across engineering functions on cross-functional projects.

Skills

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

Job description

Johnson & Johnson is seeking a Senior Compliance Engineer in Process Engineering in Schaffhausen, Switzerland. The role focuses on engineering, qualification, validation support, and aseptic process improvements to ensure regulatory compliance and product quality.

You will lead troubleshooting, support technology implementations, and collaborate with QA, production, and suppliers to drive efficiency and safety in aseptic manufacturing.