Description
Caring for the world... starting with one person. This principle inspires and unites the people at Johnson & Johnson. The culture of caring is at the heart of our corporate philosophy, which is anchored in the Credo.
Cilag AG is an international production company of the Janssen pharmaceutical division of the Johnson & Johnson Group and produces pharmaceutical and medical technology products as well as active chemical ingredients (APIs) for the global markets at its production site in Schaffhausen. Thanks to our innovative products, processes and technologies, Cilag AG is now one of the leading pharmaceutical companies in Switzerland and is also a strategic launch and growth location.
Principal Engineer, Process Engineering (m/w)
Main Tasks
* Support the operation of the process equipment and production operation at the technical level in the Fill & Finish pilot plant.
* Lead the annual Shut Down and Maintenance Group.
* Substitute for Senior Manager in CAPEX Projects during absence.
* Troubleshoot, rectify, and document issues in collaboration with production personnel, equipment suppliers, and quality assurance.
* Manage technical change and optimization processes (change control) systems and processes.
* Supervise the technical order system in cooperation with mechanics and Technical Services.
* Instruct and train employees on system and process level. Support in the evaluation and qualification of new technology platforms/processes in the aseptic environment.
* Collaborate on cross-cutting projects with other engineering functions at the local campus level and in the global engineering environment.
Qualifications
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. Conduct root-cause analysis, define corrective actions, and follow up on implementations.
* Experience in process & facility engineering, supporting GMP compliance of facility, utilities, and process equipment (e.g., COC, events, deviations, NC, qualification, support validation, etc.).
* Write procedures, protocols, analyze data, and write summary conclusions in reports.
* Experience and knowledge of Device Assembly and OI including HVAC, certification, and 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.
* Explore process proof-of-principles to build knowledge for commercial process. Plan, coordinate, and oversee 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.
* Leadership skills.
* Management of CAPEX Projects/Portfolio.
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