Senior Process Engineer
hace 2 semanas
**Our team wouldn't be the same without your enthusiasm for collaborating**Collaboration stimulates you to think big and awakens the best in the people you worked with. You are a person open to different perspectives and you are helping to turn them into robust solutions. We value your ability to work with people who have different points of view to come up with solutions that are understood and respected. You will be of great help to our workplace.You’re not the person who will settle for just any role. Neither are we. Because we’re out to create Better Care for a Better World, and that takes a certain kind of person and teams who care about making a difference. Here, you’ll bring your professional expertise, talent, and drive to building and managing our portfolio of iconic, ground-breaking brands. In this role, you’ll help us deliver better care for billions of people around the world. **It starts with** **YOU**.****In this role, you will**:- Search and implement changes in process and / or production methods to streamline routine operations thus increasing production.- Ensure compliance with the requirements of the standards and regulations of quality according to policies and procedures already established, keeping all the necessary documentation updated according to the requirements of (ISO-13485, FDA / GMP).- Coordinate with the design staff the implementation of a new product, collaborating in the RSR / MSR run; Compliance and Monitoring in time and form of the SLSW program- In the daily production meetings, the engineer will provide status of the assigned activities in the agenda when applicable; Complete activities / projects when they are assigned and provide support to others when required.- Provides training on the requirements of the process and can provide other trainings when required.- Maintains a plan, manages activities and monitors the status of scheduled changes associated with the assigned areas.- Provides recommendations on calibration and preventive maintenance of equipment, fixtures, etc. as required; Provide and support the Project Engineering department, in the process of transferring new products or improvements in the process. This support includes process development and new manufacturing codes, rate of operations, operator training, product packaging, labeling, new equipment or upgrade, etc.- Responsible for opening, coordinating activities, etc. of the Change Request according to the process established in the quality system.- Coordinates the activities related to the validation process; Responsible for making or participating in the Validation Master Plan (MVP = Master Validation Plan). This document is prepared together with the Validation Risk Assessment and establishes the details of the validation activities within the production process or another area; Responsible for the different types of Validations: Process validation, Cleaning & Sanitization validation, validation of computer systems and validation of equipment, etc.- Preparation and / or approval of protocols for each validation process: IQ, OQ & PQ, which describes the steps and measurements required, what test is necessary, what are the expected results and what should be done, if the results deviate from what is written in the protocol, is responsible for making the deviation corresponding to the validation process; Organization of data, analyzing the results of tests based on statistical software or other tools that help analyze the data.- Responsible for making validation reports, documenting and reporting the analysis of test results; Investigate the perceived changes to the product or process when notified, to determine what the validation process will do.**About Us**At Kimberly-Clark, you’ll be part of the best teams committed to driving innovation and growth. We’re founded on 150 years of market leadership, and we’re always looking for new and better ways to perform—so what can you do with that? There’s no time like the present to make an impact at Kimberly-Clark. It’s all here for you at Kimberly-Clark.**Led by Purpose. Driven by You.****About You**:You’re driven to perform at the highest level possible, and you appreciate a performance culture fueled by authentic caring. You want to be part of a company actively dedicated to sustainability, inclusion, wellbeing, and career development.To succeed in this role, you will need the following qualifications:- Professional degree in Industrial Engineering or related.- ENGLISH: Advanced level- 5 + years of experience (Medical Device Manufacturing is a plus)- Knowledge about training systems and production processes; SAP knowledge; know how to le6d work groups; project development, introduce new products, change, and improve working methods, carry out capacity studies; Analytical skills and statistics (MUST)- Any certification on Six sigma (preferable)- For Kimberly-Clark to grow and prosper, we must be a
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