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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 results.
• Overall understanding  of project budgeting processes and systems.
• Understanding of the own role and the role of the department within the broader organization (CSC/DPDS/IMSC).
• Readiness to lead a project team.
• Provides an opportunity to explore process proof-of-principles to build up of knowlage for commercial process. Plans, coordinates and oversees validation operations, including scale up  and optimization processes, equipment assembly, in process sample analysis,  use of reactors, and preparation of compliance documents.
• Evaluate analytical results to maintain and improve the quality of batches.
• Propose and determine new or improved technologies to enhance product quality, manufacturing cost efficiencies, personnel safety and regulatory compliance.
• Strong knowledge of aseptic fill finish and Annex 1/FDA compliance with all related regulatory & guidelines to translate in a technical solution
• Bilingual German & English
• 4-6 years’ of experience in the pharmaceutical/foot/chemical environment

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