Senior Compliance & Process Engineer (Aseptic GMP)

JnJ India; Schaffhausen; On-site; CHF 110,000 - 150,000; Full time

Job summary

Johnson & Johnson in Schaffhausen seeks a Senior Compliance Engineer in Process Engineering to lead engineering qualification and support validation of process equipment, utilities and computerized systems in CM&T F2P2.

In this role you will troubleshoot technical issues, manage change control, oversee technical work orders, and train operators. Fluency in German and English is required, and you will collaborate across global engineering teams in a fast-paced, regulated environment.

Qualifications

• Experience specifying and designing process equipment for aseptic environments.
• Strong troubleshooting with root-cause analysis and corrective actions.
• GMP compliance knowledge for facilities, utilities, and equipment.
• Experience writing procedures and technical reports.
• Knowledge of HVAC systems and aseptic fill/sterile operations.
• Ability to lead project teams and manage budgets.
• Experience planning validation and scale-up activities.
• Fluency in German and English (written and spoken).

Responsibilities

• Provide engineering and qualification support for process equipment and utilities.
• Lead troubleshooting and non-conformance remediation with QA and production.
• Manage change control and technical work orders.
• Deliver training and operator instructions for systems and processes.
• Support evaluation of new technologies in aseptic environments.
• Collaborate with global engineering and cross-functional teams.

Skills

Aseptic equipment design

GMP compliance

Root cause analysis

Validation support

Project coordination

German/English bilingual

Change control

Technical writing

Tools

SAP PLM

Job description

Johnson & Johnson in Schaffhausen seeks a Senior Compliance Engineer in Process Engineering to lead engineering qualification and support validation of process equipment, utilities and computerized systems in CM&T F2P2.

In this role you will troubleshoot technical issues, manage change control, oversee technical work orders, and train operators. Fluency in German and English is required, and you will collaborate across global engineering teams in a fast-paced, regulated environment.