Spring Professional
Oberdorf, Nidwalden, Switzerland
For our client, a world leading Biotechnology company situated near Solothurn we are accepting applications from highly motivated and qualified individuals for the role of Your challenges This role supports manufacturing operations in the areas of process development, tool design, machine programming & layout, machinery & equipment, continuous improvement and other duties associated with engineering support of production. Main responsibilities include (but are not limited to)Support process validation strategy and writes and executes engineering studies and process validation protocols and summary reports (Installation Qualification, Operation Qualification, Performance Qualification, Computer Software Validation and Test Method Validation).Develop and implement control plans consistent with product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc.Develop and implement appropriate process monitoring and control methods consistent with the level of process/product risk.Assess and interpret common versus special cause variation in manufacturing processing and determine adequacy of current process limits.Ensure the development of a comprehensive risk management plan for the product and processDocument, justify, review or analyze whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential noncompliance to a required standard such as the QSRsAssess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. Determine effectiveness of these techniques on previously implemented improvementsAssists in the development of manufacturing and inspection procedures.Support the Manufacturing Organization in creation, review and release of MPI & Risk Management ActivitiesResponsible to originate/oversee/assist in the creation & release of change orders (COs) through Agile PLM software.Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.Support Base Business and Production Improvement InitiativesAdditional duties as assigned.Know and follow all laws and policies that apply to one's job, and maintain thehighest levels of professionalism, ethics and compliance at all times. Your skills Bachelor of Science Degree from accredited institution in Manufacturing Engineering, MechanicalEngineering, Industrial Engineering, or a related degree.Demonstrates leadership qualities including confidence, transparency, integrity, innovation, passion, patience and tenacity.4-6 years of experience in quality engineering is required.Experience with ISO 9000, ISO 13485 and GMPExperience in Design and Process validationQuality Tools KnowledgePrevious experience working in a regulated industry, such as Medical Device is preferred.Six Sigma or Lean Sigma certification or 4 years of experience preferred.Experience with packaging, Laser, and CNC processes and equipment, preferredEnglish and German
For our client, a world leading Biotechnology company situated near Solothurn we are accepting applications from highly motivated and qualified individuals for the role of Your challenges This role supports manufacturing operations in the areas of process development, tool design, machine programming & layout, machinery & equipment, continuous improvement and other duties associated with engineering support of production. Main responsibilities include (but are not limited to)Support process validation strategy and writes and executes engineering studies and process validation protocols and summary reports (Installation Qualification, Operation Qualification, Performance Qualification, Computer Software Validation and Test Method Validation).Develop and implement control plans consistent with product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc.Develop and implement appropriate process monitoring and control methods consistent with the level of process/product risk.Assess and interpret common versus special cause variation in manufacturing processing and determine adequacy of current process limits.Ensure the development of a comprehensive risk management plan for the product and processDocument, justify, review or analyze whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential noncompliance to a required standard such as the QSRsAssess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. Determine effectiveness of these techniques on previously implemented improvementsAssists in the development of manufacturing and inspection procedures.Support the Manufacturing Organization in creation, review and release of MPI & Risk Management ActivitiesResponsible to originate/oversee/assist in the creation & release of change orders (COs) through Agile PLM software.Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.Support Base Business and Production Improvement InitiativesAdditional duties as assigned.Know and follow all laws and policies that apply to one's job, and maintain thehighest levels of professionalism, ethics and compliance at all times. Your skills Bachelor of Science Degree from accredited institution in Manufacturing Engineering, MechanicalEngineering, Industrial Engineering, or a related degree.Demonstrates leadership qualities including confidence, transparency, integrity, innovation, passion, patience and tenacity.4-6 years of experience in quality engineering is required.Experience with ISO 9000, ISO 13485 and GMPExperience in Design and Process validationQuality Tools KnowledgePrevious experience working in a regulated industry, such as Medical Device is preferred.Six Sigma or Lean Sigma certification or 4 years of experience preferred.Experience with packaging, Laser, and CNC processes and equipment, preferredEnglish and German
