Beschreibung
Packaging Project EngineerOur client is a recognized company in the medical device industry, located in the Geneva region. It operates in a highly regulated environment (GMP) and is looking for a Packaging Project Engineer to strengthen its Engineering / Technical teams. The Packaging Project Engineer will coordinate and manage projects related to subcontracted packaging activities (CMO) as well as the implementation of new support systems, in collaboration with all relevant departments and in compliance with cost, timeline, and quality requirements.Ensure the implementation of new product packaging.Provide support for master data management for all products and their lifecycle within the company.Packaging Project EngineerResponsibilities:1. Packaging Project Management- Coordinate projects related to subcontracted packaging activities (CMO) and the implementation of new support systems, from initiation to project closure.- Lead cross-functional project teams (including external partners if necessary) using project management principles: definition and monitoring of the charter and schedule, team meetings, and objectives within deadlines.- Create and update technical files related to subcontracted activities, if necessary.- Draft the documentation required for project monitoring (project plans, risk analyses, protocols and reports, technical specifications, work instructions, KPIs and purchase/expense orders, evidence log) to allow for review by competent authorities, in accordance with applicable standards.- Coordinate packaging changes or the implementation of new packaging according to the change control procedure.- Ensure that the packaging of finished products complies with labeling specifications as defined in the technical file (TD) or country-specific file, and organize the necessary approvals.- Provide the supply chain department with updated product information as well as forecasted implementation dates.- Ensure compliance with the established quality system, Good Manufacturing Practices (GMP), and company rules, as well as HSSE requirements, for all assigned activities.- Participate in company or Group projects, at the request of project managers and within their area of competence or responsibility (travel to different Group sites possible).- Participate, if necessary, in exception processes, NCMR, and contribute to the continuous improvement of production conditions.- Identify the resources necessary for the proper execution of their missions and responsibilities, and ensure regular reporting of their activities.2. Master Data Management- Manage the master data necessary for the creation of products:- Bill of Materials and associated documentation (DMR);- Production routings and production flowcharts, including subcontracting steps if applicable;- Quality Management views in the ERP;- Support for master data of purchased products or components.- Ensure the update of master data both in the company's documentation system (quality system, etc.) and in the ERP, and ensure proper archiving of old data.- Create and update the necessary articles in the company's ERP system.Your Profile:- Engineering degree or equivalent.- Minimum 2 years of experience in engineering and/or production, ideally in a regulated industrial environment.- Knowledge of Good Manufacturing Practices (GMP).- Proficiency in an SAP environment (or equivalent ERP).- Proficiency in the Microsoft Windows environment, Microsoft Project (or similar project management tool), and the Microsoft Office suite.- Analytical skills, knowing how to reconcile an overall vision with attention to detail.- Clear, precise, and customer-oriented communication of technical information, both orally and in writing.- Ease of working under tight deadlines and in a matrix organization.- Fluent in French and English (oral and written).- Sense of organization and priority management.- Ability to solve problems and make decisions.- Team spirit and sense of service.- Resilience, adaptability, and autonomy. jidda80047aen jit0625aen jpiy26aen
