JT647 - PROCESS ENGINEER I

Quality Consulting GroupHumacao, PR

About The Position

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Requirements

  • Bachelor's degree in Mechanical, Biomedical, Industrial or Chemical Engineering
  • 3+ years in validation experience
  • Availability to work first and / or second shift (If require) mainly first shift

Responsibilities

  • Generate, execute process validation plan and reports [PV: characterization, OQ, PQ] (not cleaning processes) and equipment qualification [CSV: URS, FAT, IQ, OQ, PQ, TMV] (not laboratory)
  • Provides technical and sustaining engineering support in a manufacturing area.
  • Recommends and implements equipment and process modifications to meet quality standards and improve production efficiencies, manufacturing techniques as well as production yields for existing products.
  • Integrates equipment and material capabilities to meet process module target specifications and technology target specifications.
  • Reviews product development requirements for compatibility with processing methods to determine costs and schedules.
  • Interacts with product design and development personnel to ensure that processes and designs are compatible.
  • May develop and conduct statistical analysis or recommend additions to document work.
  • Leads the innovation, development and/or optimization of new manufacturing concepts, processes and procedures for transfer to manufacturing operations.
  • This can include scouting and feasibility work, material selection, process and equipment selection, tooling fixture and equipment installation and assessment of inputs, outputs and alignment to requirements.
  • Develops manufacturing processes that are applicable to statistical process control and may develop those techniques including the measurement systems.
  • Ensures processes and procedures are in compliance with regulations.
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