JT749 - PROCESS ENGINEER II

Quality Consulting Group•Juncos, PR

11d

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
4 years of relevant experience
Proficient in validation process, CSV, PV
Proficient in Troubleshooting, Equipment Setups
Proficient in document management
Change control of Medical Devices
Equipment Commissioning / Qualification
Process Validation 4. Computer System Validation (CSV)
Manufacturing, Packaging and Laboratory Equipment
Technical experience (Trouble shooting) or any similar experience or background
Quality / Process Control / Assurance of Medical Device

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.