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Job Function:
Supply Chain EngineeringJob Sub Function:
Process EngineeringJob Category:
Scientific/TechnologyAll Job Posting Locations:
Schaffhausen SwitzerlandJob Description:
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
Lead the annual Shut Down and Engineering Groupe
Substituted ofPSenior Manager by absence in Base CAPEX Projects
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 Device Assembly and OI incl. 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.
Leadership Skills
Managing of Base CAPEX Projects/Portfolio
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
At least 8-10 years of experience in the pharmaceutical/foot/chemical environment
Required Skills:
Preferred Skills:
Agile Decision Making Business Savvy Coaching Corrective and Preventive Action (CAPA) Crisis Management Critical Thinking Disruptive Innovations Emerging Technologies Industrial Hygiene Lean Supply Chain Management Organizing Process Control Process Engineering Product Costing Program Management Project Schedule Science Technology Engineering and Math (STEM) Application Technical ResearchRequired Experience:
Staff IC
About Johnson & Johnson A t Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s larges ... View more