Senior Compliance Engineer – Aseptic Process Engineering

Johnson & Johnson Innovative Medicine; Schaffhausen; On-site; CHF 120,000 - 180,000; Full time

Job summary

Johnson & Johnson Innovative Medicine in Schaffhausen, Switzerland, seeks a Senior Compliance Engineer, Process Engineering, to lead aseptic process engineering and qualification efforts in CM&T F2P2. You will support operation of the Fill & Finish pilot plant, drive change control and ensure regulatory compliance.

The role requires strong troubleshooting, GMP knowledge, and the ability to collaborate across engineering, quality, and production teams in a global organization.

Qualifications

• Proven experience specifying and designing process equipment and systems for aseptic environments.
• Strong troubleshooting skills with root cause analysis and corrective actions.
• Experience in GMP compliance for facilities, utilities and equipment.
• Experience writing procedures, analyzing process data and generating technical reports.
• Knowledge of HVAC systems and aseptic manufacturing advantages.
• Ability to lead projects and manage cross-functional teams.
• Fluent in German and English (written and spoken).

Responsibilities

• Provide technical support for operation of process equipment and production in the Fill & Finish pilot plant.
• Lead troubleshooting, corrective action and documentation efforts for technical issues and non-conformances, collaborating with production teams, equipment suppliers and Quality Assurance.
• Manage technical changes and optimization initiatives through the change control process.
• Oversee the technical work order system in cooperation with mechanics and Technical Services.
• Deliver training and instructions to operators and staff at system and process level.
• Support evaluation, qualification and implementation of new technology platforms/processes in an aseptic environment.
• Collaborate across engineering functions locally and within the global engineering organization on cross-functional projects.

Skills

Process Engineering

Aseptic Fill-Finish

Troubleshooting

Documentation

GMP Compliance

HVAC Systems

German & English

Tools

SAP Product Lifecycle Management

Job description

Johnson & Johnson Innovative Medicine in Schaffhausen, Switzerland, seeks a Senior Compliance Engineer, Process Engineering, to lead aseptic process engineering and qualification efforts in CM&T F2P2. You will support operation of the Fill & Finish pilot plant, drive change control and ensure regulatory compliance.

The role requires strong troubleshooting, GMP knowledge, and the ability to collaborate across engineering, quality, and production teams in a global organization.