Process & Equipment Characterization Engineer

Virtue America; Ohio; On-site; USD 95,000 - 125,000; Full time

Job summary

Virtue America is seeking a Process & Equipment Characterization Engineer to support assembly and packaging equipment characterization, process optimization, and equipment qualification in a regulated manufacturing environment. The role requires hands-on DOE, data analysis, and protocol execution across IQ/OQ/PQ activities.

The ideal candidate will have 5+ years in manufacturing or validation engineering, strong knowledge of GMP, FDA regulations, and ISO 13485, and experience with DOE, process

Qualifications

• 5+ years in manufacturing, process, or validation engineering.
• Hands-on experience with DOE, process optimization, and equipment qualification.
• Knowledge of GMP, FDA regulations, and ISO 13485.

Responsibilities

• Perform DOE studies, process characterization, and parameter optimization.
• Analyze data using Minitab, SPC, Cp/Cpk, and MSA/Gage R&R.
• Execute IQ/OQ/PQ protocols and verify equipment against URS.
• Troubleshoot process issues and perform root cause analysis.
• Develop PFMEAs, Control Plans, and technical reports.
• Support commissioning and startup of assembly and packaging equipment.

Skills

DOE

Data analysis

Minitab

SPC

Cp/Cpk

MSA/Gage R&R

IQ/OQ/PQ

PFMEAs

Control Plans

Root cause analysis

Tools

Minitab

URS

Job description

We’re Hiring: Process & Equipment Characterization Engineer

Location: OH-Onsite

Experience: 5+ Years

Industry: Pharma / Medical Device Manufacturing

We are looking for a Process & Equipment Characterization Engineer with experience in regulated manufacturing environments to support assembly and packaging equipment characterization, process optimization, and equipment qualification.

Key Responsibilities

• Perform DOE studies, process characterization, and parameter optimization.
• Analyze data using Minitab, SPC, Cp/Cpk, and MSA/Gage R&R.
• Execute IQ/OQ/PQ protocols and verify equipment against URS.
• Troubleshoot process issues and perform root cause analysis.
• Develop PFMEAs, Control Plans, and technical reports.
• Support commissioning and startup of assembly and packaging equipment.

Requirements

• 5+ years of manufacturing, process, or validation engineering experience.
• Hands-on experience in DOE, process optimization, and equipment qualification.
• Knowledge of GMP, FDA regulations, and ISO 13485.
• Medical device, assembly/packaging equipment, and commissioning experience preferred.