Senior Compliance Engineer, Process Engineering

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Job Function:
R&D Product Development

Job Sub Function:
R&D Process Engineering

Job Category:
Scientific/Technology

All Job Posting Locations:
Schaffhausen, Switzerland

Job Description:

Senior Compliance Engineer, Process Engineering (m/f)

Main Tasks

The Senior Compliance Engineer, Process Engineering, is responsible for Engineering and Qualification; support Validation on process equipment, utilities & facilities and computerized systems in CM&T F2P2.


* 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.

Your profile


* Proven experience specifying and designing process equipment and systems for aseptic environments.


* Strong troubleshooting skills: perform root cause analysis, define corrective actions and ensure implementation and follow-up.


* Experience in process and facility engineering with hands-on support for GMP compliance of facilities, utilities and process equipment (e.g., change controls, deviations, NCs, qualifications, support for validation).


* Experience writing procedures and protocols, analysing process data and producing clear technical reports with conclusions and recommendations.


* Knowledge of HVAC systems, certification and monitoring; previous aseptic-fill/sterile manufacturing experience is an advantage.


* Ability to identify improvement projects, create project plans and participate ...