JT934 - SR. PROCESS ENGINEER

Quality Consulting Group•Juncos, PR

12d•Onsite

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)
2+ years in experience in Process Validation and / Computer System Validations
Knowledge in Medical Devices regulations
Experience working and executing Design transfer activities
Basic knowledge in defining validation strategies (e.g requirements flow down from design to manufacturing)
Experience with Risk management documentation: pFMEAs
Basic knowledge in statistics (preferably using Minitab)
Experience with projects: design requirements validation, manufacturing controls (not Operational Excellence)
2+plus year in validation experience
Onsite, Full time
12 Hour Day Shift
Availability to work extended shifts (8- 12 hours per shift)
Availability to work weekends (Saturday and/or Sundays)
Availability to work Holidays as require
Availability to work first and / or second shift (If require) mainly 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.