JT718 - SR. PROCESS ENGINEER

Quality Consulting GroupJuncos, PR
2dOnsite

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 Engineering (Mechanical, Electrical, or Chemical preferred)
  • Hands-on experience managing process, performing troubleshooting and implementation of projects.
  • Candidates should have specific technical expertise in one or more of the following areas: pneumatics, laser, welding, ultrasonic joining, sensors and control systems, robotics, servo systems, sealing and packaging, vision systems, bonding processes, cleaning processes and injection molding.
  • Knowledgeable on basic Process Controls (software, electrical, and mechanical) requirements typical of an automated process, Including, PLC, HMI, vision systems, and motion controls.
  • Minimum of 5 years of experience in Validation protocols and reports such as: Equipment IQ, Computer System Validations, Process Characterizations, Process OQ/PQ
  • Knowledge in Medical Devices regulations
  • Availability to work first shift

Responsibilities

  • 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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