JT749 - PROCESS ENGINEER II

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.

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.

Qualifications : 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 1st shift (8am to 5pm) Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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