Senior Aseptic Process Engineer, Compliance

Johnson Johnson

Schaffhausen

On-site

CHF 110,000 - 150,000

Full time

3 days ago

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Job summary

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

You will provide technical support for operation of process equipment, lead troubleshooting, manage change controls, and collaborate across global engineering teams to drive compliance and process improvements.

Qualifications

Experience specifying and designing process equipment for aseptic environments.
Strong troubleshootingskills including root cause analysis and corrective actions.
Experience with GMP compliance of facilities, utilities & equipment, deviations and qualifications.
Experience writing procedures and protocols, analyzing process data and producing reports.
Knowledge of regulatory requirements and aseptic fill/finish operations is a plus.

Responsibilities

Provide technical support for operation of process equipment and production in the Fill & Finish pilot plant.
Lead troubleshooting, corrective action and documentation for technical issues and non-conformances.
Manage changes and optimization initiatives through the change control process.
Oversee the technical work order system 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 aseptically.
Collaborate across engineering functions locally and globally on cross-functional projects.