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Process Engineer - Validation 100% m/f/d

Req ID: J2260479

  • 地点
    海根多夫, 索洛图恩, Switzerland
  • 类别 工程
  • 发表 2021年2月19日
  • 类型 全职工作

职位描述

Advance your career and move global healthcare forward. Join the world's largest healthcare design and manufacturing services company where we create, design, and manufacture products and solutions that improve patient health for the leading healthcare brands of the world.

To enhance our team , we are looking for:

Process Engineer Validation 100% m/f/d

Tasks

  • Support attainment of key business metrics through the provision of engineering support for value stream processes.

  • Elimination of safety and quality risks in the process through the delivery of robust engineering solutions.

  • Manage costs through the delivery of scrap, reprocessing and consumable projects.

  • Design & develop tools, fixtures, gauges and special equipment for manufacturing operations in conjunction with Toolroom Technicians and outside vendors.

  • Develop stable and capable manufacturing processes through a structured process development approach.

  • Preparation of all relevant manufacturing specifications. HS&E

  • Actively promote a safety culture.

  • Manage contractors / vendors working on site to ensure full compliance with site safety requirements.

  • Ensure production equipment meets all relevant national and J&J Health, Safety and Environment requirements through completion of required assessments and documentation.

  • Competent in validation requirements for new consumables / materials and process changes.

  • Updates and maintenance of manufacturing specifications for process steps.

  • Ensure timely closure of quality actions such as Audit Actions, NCR’s, CAPA’s.

  • Ensure all process development, validation, etc. is managed in accordance with the Quality management system.

  • Support day to day operations through attendance at pulse walks and the timely closure of actions.

  • Root Cause Analysis and implementation of robust solutions to supply and quality issues as they arise through tools such as 8D and Six Sigma.

  • Project Management - provide timely and accurate reporting on project activities ensuring projects are delivered to agreed timelines.

  • Manage the consumables budget for the assigned value stream identifying opportunities for cost reduction and managing the delivery of savings.

  • Lead scrap reduction within the value stream through a structured approach to data capture, analysis and problem solving.

  • Identify and lead cost and technical improvements under the department’s continuous improvement program.

  • Provide process input into the value stream mapping process which is used to develop the business plan for the value stream.

  • Determine equipment layouts for manufacturing cells using Lean Manufacturing tool as identified.

  • Actively interface with cross-functional team members, always practicing good team work in support of day to day operating and project requirements.

  • Demonstrate strong leadership and a clear identifiable work ethos within the Engineering team.

  • Develop and maintain a Credo & Behavioral Standards based culture within the Engineering team.

  • Work with Team Lead and/or Manager to develop and implement strategic engineering Goals & Objectives.

  • Support the implementation of all engineering and plant strategic initiatives.

  • Write the necessary process Validation documentation required by the Quality Management System, ensuring compliance with regulatory bodies (FDA, HPRA, NSAI) directives / requirements applicable to the Medical Device Sector.

  • Generate and support the execution of Master Validation Plans, Validation/Qualification Protocols and Validation/Qualification Reports

  • Establishing validation strategies for NPI within multidisciplinary teams.

  • Establishing validation strategies for transfer within facilities.

Requirements

  • min. Bachelor Degree in relevant engineering science field

  • min. 4 years experience in a related field

  • Previous experience in validation of surface treatment processes

  • Excellent english skills - german is a plus

What is like working with us

  • Professional environment that prides itself in awarding long-term service

  • International environment and network

  • On-job, in-class and online trainings

  • Global company with local roots 

  • Attractive benefits and holiday allowance

Interested? Please apply by clicking the button below.

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