Sr Compliance Engineer

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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:

Compliance Engineer, Process Engineering (m/f)

Main Task

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


* Support the operation of the process equipment and production operation at the technical level in the Fill & Finish pilot plant


* Troubleshooting, rectification and documentation (troubleshooting, non-conformance management) in collaboration with production personnel, equipment suppliers and quality assurance


* Management of technical change and optimization processes (change control) systems and processes


* Supervision of the technical order system in cooperation with mechanics and Technical Services


* Instruction and training of employees on system and process level.

Support in the evaluation and qualification of new technology-platforms/processes in the aseptic environment


* Cross-cutting project collaboration with other engineering functions at the local campus level and in the global engineering environment

Your profile



* Specifications & design of process equipment and systems in the aseptic environment.


* Troubleshoot equipment failures and define optimization and / or changes to existing equipment.

Root-cause analyzation , definition of corrective actions and follow-up of implementations.


* Building experience in process & facility engineering, support GMP-compliance of facility, utilities and process equipment (e.g.

COC, events, deviations, NC, qualification, support validation, ...)


* Write procedures, protocols, analyse data and write summary conclusions in reports.


* Building experience and knowledge of HVAC, certification, monitoring - Additional experience in the aseptic field is welcome


* Identify projects, create project plans and participate in their implementation.

Perform evaluations to drive efficiency and business res...