Matrix Process Engineer - CDD 1 an-00000MAR
Description
- Manage manufacturing process based projects, in line with agreed targets and priorities of Business Units
- Lead equipment and process improvements projects
- Lead new equipment or duplication of equipment projects
- Conceive, develop and implement equipment / tooling and support the respective equipment installation qualification activities
- Lead technical investigations and feasibility studies as required for specific projects/tasks
- Exercise technical judgment within broadly defined practices and policies in selecting process development and validation strategies
- Work with vendors to procure new equipment and ensure new equipment and processes conform to HSE guidelines
- Be responsible for performing and documenting activities for IQ, OQ and PQ
- Serve as the engineering approver for process development studies and validation documentation when authorized
- Follow process performance metrics and initiate appropriate actions
- Provide the technical input to plan, design, develop, and validate the manufacturing processes for new products working with cross-functional teams including: R&D, Quality Engineering, Regulatory, Procurement, Manufacturing, and Environmental/Safety
- Be accountable for appropriate improvement and execution of process and validation activities at external suppliers as required. Support raw material and supplier qualifications
- Support closure of NCRs, CAPAS, audit observations, ergonomics and safety related action items
- Serve as the process and equipment engineering to support manufacturing / Take on the responsibility for the analysis and disposition of process related defects
- Technical writing, data analysis, data tracking and trending
- Take the responsibility for the transfer of the technical know-how to operators and technicians
- Provide technical information on appropriate areas to all functions within the business
- Provide project updates and presentations to all levels of the business
- Identify, quantify, and implement opportunities to reduce cost of goods
- Apply project management methodology to deliver on process improvements, new process implementation & equipment development/Improvement
- Ensure that all activities are carried out in accordance with appropriate internal and external Health, Safety & Environment procedures and safe working conditions and practices and supporting documents are in place. Observe all regulatory requirements (GMP's, ISO, FDA, internal policies) applicable to their area of responsibility
- Maintain project documentation and files and, where appropriate, suggest improvements to systems and procedures
- Ensure that all assigned activity is carried out in accordance with appropriate internal and external quality systems
Qualifications
- Engineering degree
- Mechanical background with up to 3 to 5 years in industry (Engineer) - Experience with medical environment will be appreciated
- Experience in Manufacturing and/or Engineering working on manufacturing processes and improvements
- Knowledge on Textile Material could be useful for the position
- Thorough working knowledge of the validation requirements for Medical Devices with demonstrated experience; generate and execute equipment, process, and computer system validation
- Demonstrated ability to select and execute the appropriate statistical tools and provide the practical conclusions and inferences during the process development and validation activities. Understanding of process variability and process control
- Working knowledge of Six Sigma/Process Excellence Tools (DMAIIC, DMADV, or Lean) which include Design of Experiments, capability analysis, C/E Matrix, pFMEA, fish bone diagrams, etc
- Proficiency with Microsoft Office and a working knowledge of statistical software is required. Candidates who have experience using MiniTab are preferred
- Project management, resource prioritization, demonstrated experience in the development and execution of project plans (including time, budget and quality metrics) will be appreciated.
- Resistance to stress
- Good organization skills and results oriented
- Excellent communication skills; making complex issues easy for others to understand and the ability to prepare communications for team and project documentation. Ability to communicate across multiple levels in the organization
- Demonstrated proficiency in regulatory compliance
- Ability to work in a team environment
- Fluent in English and French
Able to travel up to 20%
Primary Location:Europe/Middle East/Africa-Switzerland-Neuchâtel-Neuchâtel
Organization: ETHICON Women's Health & Urology Sarl (8566)
Job Function: Process Engineering
Description
- Manage manufacturing process based projects, in line with agreed targets and priorities of Business Units
- Lead equipment and process improvements projects
- Lead new equipment or duplication of equipment projects
- Conceive, develop and implement equipment / tooling and support the respective equipment installation qualification activities
- Lead technical investigations and feasibility studies as required for specific projects/tasks
- Exercise technical judgment within broadly defined practices and policies in selecting process development and validation strategies
- Work with vendors to procure new equipment and ensure new equipment and processes conform to HSE guidelines
- Be responsible for performing and documenting activities for IQ, OQ and PQ
- Serve as the engineering approver for process development studies and validation documentation when authorized
- Follow process performance metrics and initiate appropriate actions
- Provide the technical input to plan, design, develop, and validate the manufacturing processes for new products working with cross-functional teams including: R&D, Quality Engineering, Regulatory, Procurement, Manufacturing, and Environmental/Safety
- Be accountable for appropriate improvement and execution of process and validation activities at external suppliers as required. Support raw material and supplier qualifications
- Support closure of NCRs, CAPAS, audit observations, ergonomics and safety related action items
- Serve as the process and equipment engineering to support manufacturing / Take on the responsibility for the analysis and disposition of process related defects
- Technical writing, data analysis, data tracking and trending
- Take the responsibility for the transfer of the technical know-how to operators and technicians
- Provide technical information on appropriate areas to all functions within the business
- Provide project updates and presentations to all levels of the business
- Identify, quantify, and implement opportunities to reduce cost of goods
- Apply project management methodology to deliver on process improvements, new process implementation & equipment development/Improvement
- Ensure that all activities are carried out in accordance with appropriate internal and external Health, Safety & Environment procedures and safe working conditions and practices and supporting documents are in place. Observe all regulatory requirements (GMP's, ISO, FDA, internal policies) applicable to their area of responsibility
- Maintain project documentation and files and, where appropriate, suggest improvements to systems and procedures
- Ensure that all assigned activity is carried out in accordance with appropriate internal and external quality systems
Qualifications
- Engineering degree
- Mechanical background with up to 3 to 5 years in industry (Engineer) - Experience with medical environment will be appreciated
- Experience in Manufacturing and/or Engineering working on manufacturing processes and improvements
- Knowledge on Textile Material could be useful for the position
- Thorough working knowledge of the validation requirements for Medical Devices with demonstrated experience; generate and execute equipment, process, and computer system validation
- Demonstrated ability to select and execute the appropriate statistical tools and provide the practical conclusions and inferences during the process development and validation activities. Understanding of process variability and process control
- Working knowledge of Six Sigma/Process Excellence Tools (DMAIIC, DMADV, or Lean) which include Design of Experiments, capability analysis, C/E Matrix, pFMEA, fish bone diagrams, etc
- Proficiency with Microsoft Office and a working knowledge of statistical software is required. Candidates who have experience using MiniTab are preferred
- Project management, resource prioritization, demonstrated experience in the development and execution of project plans (including time, budget and quality metrics) will be appreciated.
- Resistance to stress
- Good organization skills and results oriented
- Excellent communication skills; making complex issues easy for others to understand and the ability to prepare communications for team and project documentation. Ability to communicate across multiple levels in the organization
- Demonstrated proficiency in regulatory compliance
- Ability to work in a team environment
- Fluent in English and French
Able to travel up to 20%
Primary Location:Europe/Middle East/Africa-Switzerland-Neuchâtel-Neuchâtel
Organization: ETHICON Women's Health & Urology Sarl (8566)
Job Function: Process Engineering