Manufacturing Process Engineer II – Validation & SOPs

Quality Consulting Group, LLC

Northern (KY)

Hybrid

USD 90,000 - 120,000

Full time

7 days ago

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Job summary

Quality Consulting Group, LLC specializes in pharmaceutical, biotech, medical devices, and manufacturing sectors across Puerto Rico and the USA. This role targets a Process Development Engineer who will help introduce new products and optimize production layouts, processes, and tooling for efficiency and quality.

A Bachelor’s degree in Engineering and 3+ years of experience are required, with expertise in IQ/OQ/PQ, DOE, CSV, and MES systems.

Qualifications

Bachelor’s degree in Engineering.
3+ years of relevant experience.
Process Development and documentation.
Equipment validation.
SOP Development.
Special Build Documentation and Line Support.
Experience in equipment IQ.
Experience in OQ and PQ and/or process validation.
Process Validation Lifecycle (from process characterization, operational qualification to performance qualification).
Preferred experience in DOE (with Minitab).
Computer and software validation CSV.
SOP Development.
Change control of Medical Devices.
MES system.
Shift: 1st shift.

Responsibilities

Working on the introduction on a new product and/or components.
Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.
Designs arrangement of machines within plant facilities to ensure most efficient and productive layout.
Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance.
Adapts machine or equipment design to factory and production conditions.
May incorporate inspection and test requirements into the production plan.
Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.
Develops manufacturing processes that are applicable to statistical process control and may develop those techniques.