Quality Engineer, Validation Consultant
A multinational biopharmaceutical that operates across the globe is seeking a Quality Engineer to join their team in Le Locle, Switzerland.
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.
- 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 the adequacy of current process limits.
- Ensure the development of a comprehensive risk management plan for the product and process
- Document, 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 non-compliance to a required standard such as the QSRs
- Assess 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 improvements
- Assists in the development of manufacturing and inspection procedures.
- Support the Manufacturing Organization in creation, review and release of MPI & Risk Management Activities
- Responsible 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 Initiatives
Education, Skills and Experience:
- Bachelor of Science Degree from an accredited institution in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or a related degree.4-6 years of experience in quality engineering is required.
- Experience with ISO 9000, ISO 13485 and GMP
- Experience in Design and Process validation
- Previous 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, preferred
- Demonstrates leadership qualities including confidence, transparency, integrity, innovation, passion, patience and tenacity.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Caleb Mensah on +44 203 854 1080 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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