Sr Compliance Engineer (Pharmaceutical Manufacturing)

Location: Schaffhausen, Switzerland

Company

Johnson & Johnson MedTech develops healthcare and medical technology solutions focused on improving patient outcomes.

What you will do

• Engineer and qualify process equipment, utilities, facilities, and computerized systems, while supporting validation activities.
• Provide technical support for process equipment and production operations in the aseptic Fill & Finish pilot plant.
• Troubleshoot equipment failures, manage non-conformances, define corrective actions, and document resolutions with production, suppliers, and Quality Assurance.
• Manage technical changes, process optimizations, and the technical order system in cooperation with mechanics and Technical Services.
• Train employees on systems and processes and support the evaluation and qualification of new aseptic technologies.
• Lead or contribute to local and global engineering projects, including validation operations, scale-up, process optimization, and compliance documentation.

Requirements

• 4–6 years of experience in pharmaceutical, food, or chemical environments.
• Experience with process and facility engineering and GMP compliance for facilities, utilities, and process equipment.
• Knowledge of aseptic Fill & Finish and the ability to translate Annex 1, FDA, and related regulatory requirements into technical solutions.
• Experience with equipment specifications, design, troubleshooting, root-cause analysis, corrective actions, qualification, validation support, and technical documentation.
• Knowledge of HVAC, certification, and monitoring; additional aseptic manufacturing experience is beneficial.
• Bilingual German and English, with readiness to lead project teams.

Nice to have

• Experience with SAP Product Lifecycle Management.
• Knowledge of emerging technologies, process control, product costing, and vendor selection.

Culture & Benefits

• Inclusive work environment that respects individual dignity, diversity, and merit.
• Cross-functional collaboration across the local campus and global engineering organization.
• Opportunity to develop proof-of-principle process knowledge for commercial manufacturing.