Process Validation Engineer (Medical Devices), Chonburi

Executive recruitment company Monroe Consulting Group Thailand is recruiting on be half of a global leader in electronics industry. We are seeking a Process Validation Engineer to join our dynamic team. This job requires technical experience related to validation of products for high-value industry, such as medical devices and pharmaceutical products.

The Process Validation Engineer will be responsible for validating/qualifying the processes, systems, equipment, facilities, and/or utilities used to manufacture electronic parts for medical devices. This position needs to be comfortable working with cross-functional engineering teams, HQ teams and customers to successfully launch the new production.

Job Responsibilities

  • Lead the cross-functional team members to transfer consumable and instruments prior to new product launch.
  • Executes validation activities to include Change Control initiation, protocol preparation, scheduling, protocol execution, data review and final report generation.
  • Create the Site Master Validation Plan (overall picture and scope of the whole site, not for the individual project) and track it throughout the whole year according to the plan, could be revised if any big changes (Need gather information from other owners as inputs)
  • Participates on teams assembled to specify, install, validate, troubleshoot and maintain processes, systems and equipment.
  • Interacts with product design and development personnel to ensure that processes and designs are compatible.
  • Create Project Master Validation Plan for the NPI project and IQ/OQ/PQ protocol & report for process & product related. Create Software validation protocol & report
  • Integrates equipment and material capabilities to meet process module target specifications and technology target specifications.
  • Handle all front-end quality engineering; bring the requirement to deploy to QA team, rreview FMEA with product or process design engineer and the team andlaunch control plan for all new projects.
  • Supervise Calibration Lab Specialist, develop and sustain all activities to comply with ISO standards and relevant regulations.
  • Participate and present data in Regulatory Agency, Customer, Corporate and Internal audits(ISO9001 and ISO13485) when necessary.

Job Requirements

  • Bachelor's degree, or completion of a minimum of two years of study, in Mechanical, Electrical, Industrial, or Process engineering.
  • Experience with best practices and continuous improvement initiatives.
  • Working knowledge of Lean/5s.
  • The ability to manage multiple ongoing projects.
  • In-depth knowledge of Microsoft Office Suite (particularly Excel, Access and Visio).
  • Experience in automation would be an asset.
  • Knowledge of HACCP, GMP's, SQF.
  • Strong diagnostic skills, problem-solving and change management