Senior Compliance Engineer, Process Engineering

About the role

Johnson & Johnson is hiring a Senior Compliance Engineer for its Process Engineering team in Schaffhausen, Switzerland. The role covers engineering and qualification of process equipment, utilities and facilities, and computerized systems in the CM&T F2P2 area, supporting validation and aseptic fill and finish operations.

Key responsibilities

• Support validation of process equipment, utilities and facilities and computerized systems.
• Provide technical support for the operation of process equipment and production in the Fill & Finish pilot plant.
• Lead troubleshooting, corrective action and documentation for technical issues and non-conformances, working with production teams, equipment suppliers and Quality Assurance.
• Manage technical changes and optimization through the change control process.
• Oversee the technical work order system together with mechanics and Technical Services.
• Train operators and staff at system and process level.
• Evaluate, qualify and implement new technology platforms and processes in an aseptic environment.
• Collaborate on cross-functional projects locally and within the global engineering organization.

Required profile

• Proven experience specifying and designing process equipment and systems for aseptic environments.
• Strong troubleshooting skills, including root cause analysis and corrective actions.
• Process and facility engineering experience with hands-on GMP compliance support (change controls, deviations, non-conformances, qualifications, validation support).
• Experience writing procedures and protocols, analysing process data and producing technical reports.
• Knowledge of HVAC systems, certification and monitoring; aseptic fill/sterile manufacturing experience is an advantage.
• Ability to plan and coordinate validation and scale-up, equipment assembly, in-process sampling and compliance documentation.
• Ability to evaluate analytical results to maintain batch quality and propose improvements for product quality, cost-efficiency, safety and regulatory compliance.
• 4-6 years' experience in the pharmaceutical, food or chemical industry.
• Fluent German and English, written and spoken.

Required skills

• Solid knowledge of aseptic fill-finish operations and regulatory requirements (Annex 1 / FDA guidance)
• Change control and validation support
• Technical writing and reporting
• Project planning and coordination