Validation Engineer
Location: NetherlandsSIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Medical Devices organisation, based in Zuid-Holland Netherlands.
• Responsible for performing and documenting activities for IQ, OQ and PQ;
• Follow compliance and EHS&S policies and guidelines;
• Identify, quantify, and implement opportunities to reduce cost of goods;
• Support closure of NCRs, CAPAS, audit observations, ergonomics and safety related action items;
• Work with vendors to procure new equipment and ensure new equipment and processes conform to EHS&S guidelines;
• Technical writing, data analysis, data tracking and trending;
• Manage manufacturing process based projects, in line with agreed targets and priorities of Business Units;
• Serve as the process and equipment engineering to support manufacturing;
• Serve as the engineering approver for process development studies and validation documentation when authorized;
• Apply project management methodology to deliver on process improvements, new process implementation & equipment development/Improvement;
• Lead technical investigations and feasibility studies as required for specific projects/tasks;
• Provide technical information on appropriate areas to all functions within the business;
• Exercises technical judgment within broadly defined practices and policies in selecting process development and validation strategies;
• 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;
• Conceive, develop and implement equipment / tooling and support the respective equipment installation qualification activities;
• Accountable for appropriate improvement and execution of process and validation activities at external suppliers as required;
• Provide project updates and presentations to all levels of the business;
• Ensure 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 all assigned activity is carried out in accordance with appropriate internal and external quality systems.
• Responsible for performing and documenting activities for IQ, OQ and PQ;
• Follow compliance and EHS&S policies and guidelines;
• Identify, quantify, and implement opportunities to reduce cost of goods;
• Support closure of NCRs, CAPAS, audit observations, ergonomics and safety related action items;
• Work with vendors to procure new equipment and ensure new equipment and processes conform to EHS&S guidelines;
• Technical writing, data analysis, data tracking and trending;
• Manage manufacturing process based projects, in line with agreed targets and priorities of Business Units;
• Serve as the process and equipment engineering to support manufacturing;
• Serve as the engineering approver for process development studies and validation documentation when authorized;
• Apply project management methodology to deliver on process improvements, new process implementation & equipment development/Improvement;
• Lead technical investigations and feasibility studies as required for specific projects/tasks;
• Provide technical information on appropriate areas to all functions within the business;
• Exercises technical judgment within broadly defined practices and policies in selecting process development and validation strategies;
• 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;
• Conceive, develop and implement equipment / tooling and support the respective equipment installation qualification activities;
• Accountable for appropriate improvement and execution of process and validation activities at external suppliers as required;
• Provide project updates and presentations to all levels of the business;
• Ensure 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 all assigned activity is carried out in accordance with appropriate internal and external quality systems.
• Electrical, Automation or Mechanical background with up to 2 to 10 years in industry (Engineer) - with preferably significant Experience in medical environment;
• Experience in Manufacturing and/or Engineering working on manufacturing processes and improvements;
• Understanding of process variability and process control;
• Lean and/or Six Sigma;
• Project management and resource prioritization;
• Strong time, budget, and program management skills;
• Demonstrated experience in the development and execution of project plans;
• 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;
• 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;
• 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 with a driver mentality;
• Fluent in English, Dutch will be a plus.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Michelle Tang.
The Company
Mentor Medical Systems is a leading supplier of medical products for the global aesthetic medicine market. The company develops, manufactures, and markets innovative, science-based products for aesthetics markets around the world. The Engineering department is responsible for the long-term planning, development, qualification and implementation of next generation manufacturing processes and automation technologies.Role Description
• Lead equipment and process improvements projects;• Responsible for performing and documenting activities for IQ, OQ and PQ;
• Follow compliance and EHS&S policies and guidelines;
• Identify, quantify, and implement opportunities to reduce cost of goods;
• Support closure of NCRs, CAPAS, audit observations, ergonomics and safety related action items;
• Work with vendors to procure new equipment and ensure new equipment and processes conform to EHS&S guidelines;
• Technical writing, data analysis, data tracking and trending;
• Manage manufacturing process based projects, in line with agreed targets and priorities of Business Units;
• Serve as the process and equipment engineering to support manufacturing;
• Serve as the engineering approver for process development studies and validation documentation when authorized;
• Apply project management methodology to deliver on process improvements, new process implementation & equipment development/Improvement;
• Lead technical investigations and feasibility studies as required for specific projects/tasks;
• Provide technical information on appropriate areas to all functions within the business;
• Exercises technical judgment within broadly defined practices and policies in selecting process development and validation strategies;
• 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;
• Conceive, develop and implement equipment / tooling and support the respective equipment installation qualification activities;
• Accountable for appropriate improvement and execution of process and validation activities at external suppliers as required;
• Provide project updates and presentations to all levels of the business;
• Ensure 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 all assigned activity is carried out in accordance with appropriate internal and external quality systems.
Responsibilities
• Lead equipment and process improvements projects;• Responsible for performing and documenting activities for IQ, OQ and PQ;
• Follow compliance and EHS&S policies and guidelines;
• Identify, quantify, and implement opportunities to reduce cost of goods;
• Support closure of NCRs, CAPAS, audit observations, ergonomics and safety related action items;
• Work with vendors to procure new equipment and ensure new equipment and processes conform to EHS&S guidelines;
• Technical writing, data analysis, data tracking and trending;
• Manage manufacturing process based projects, in line with agreed targets and priorities of Business Units;
• Serve as the process and equipment engineering to support manufacturing;
• Serve as the engineering approver for process development studies and validation documentation when authorized;
• Apply project management methodology to deliver on process improvements, new process implementation & equipment development/Improvement;
• Lead technical investigations and feasibility studies as required for specific projects/tasks;
• Provide technical information on appropriate areas to all functions within the business;
• Exercises technical judgment within broadly defined practices and policies in selecting process development and validation strategies;
• 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;
• Conceive, develop and implement equipment / tooling and support the respective equipment installation qualification activities;
• Accountable for appropriate improvement and execution of process and validation activities at external suppliers as required;
• Provide project updates and presentations to all levels of the business;
• Ensure 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 all assigned activity is carried out in accordance with appropriate internal and external quality systems.
Requirements
• Engineering degree;• Electrical, Automation or Mechanical background with up to 2 to 10 years in industry (Engineer) - with preferably significant Experience in medical environment;
• Experience in Manufacturing and/or Engineering working on manufacturing processes and improvements;
• Understanding of process variability and process control;
• Lean and/or Six Sigma;
• Project management and resource prioritization;
• Strong time, budget, and program management skills;
• Demonstrated experience in the development and execution of project plans;
• 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;
• 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;
• 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 with a driver mentality;
• Fluent in English, Dutch will be a plus.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Michelle Tang.
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