Process & Equipment Characterization Engineer

Title : Process & Equipment Characterization Engineer

Location: Ohio (Onsite)
Employment Type: Contract W2
Duration: 1+ Year
Rate: $45 $47/hr W2
Experience: 4+ Years
Industry: Pharmaceutical / Medical Device Manufacturing

About the Role

We are seeking a Process & Equipment Characterization Engineer to support the characterization and optimization of assembly and packaging equipment in a regulated manufacturing environment. This role focuses on defining process parameters, establishing operating windows, analyzing process capability, and verifying equipment performance to ensure readiness for qualification and production.

Key Responsibilities

• Design and execute process and equipment characterization studies, including Design of Experiments (DOE), engineering runs, parameter mapping, and sampling studies.

• Establish process windows and optimal operating parameters for manufacturing equipment and processes.

• Analyze study data using statistical tools such as Minitab to evaluate process variation, SPC, and process capability (Cp/Cpk).

• Author, execute, and document characterization and qualification protocols, including IQ/OQ/PQ.

• Evaluate equipment functionality against User Requirement Specifications (URS) and confirm alignment with design requirements.

• Troubleshoot equipment and process issues and lead root cause investigations using 8D, 5-Why, or similar methodologies.

• Identify equipment deficiencies and recommend data-driven corrective actions.

• Support commissioning, installation, and startup of automated and PLC-controlled assembly and packaging equipment.

• Develop and update PFMEAs, Control Plans, and technical reports based on study findings.

• Collaborate with Engineering, Validation, Quality, Automation, and Manufacturing teams to resolve technical issues and ensure equipment readiness.

Required Qualifications

• At least 4 years of experience in manufacturing, process, or validation engineering within a regulated environment.

• Hands-on experience with process characterization, DOE, parameter optimization, and process window definition.

• Strong statistical analysis skills, including SPC, process capability analysis (Cp/Cpk), and Measurement System Analysis (MSA/Gage R&R).

• Experience with equipment qualification, including IQ/OQ/PQ, and protocol authoring and execution.

• Experience with root cause analysis, PFMEA, and Control Plans.

• Familiarity with applicable FDA regulations, including 21 CFR Part 820 and Parts 210/211, ISO 13485, and GMP requirements.

• Strong analytical, troubleshooting, documentation, and cross-functional collaboration skills.

• Ability to work onsite in Ohio.

Preferred Qualifications

• Direct experience with assembly or packaging equipment.

• Medical device or combination product manufacturing experience.

• Experience with commissioning, installation, and startup in a regulated manufacturing environment.

• Proficiency with Minitab or comparable statistical analysis software.

• Experience with automated manufacturing equipment and PLC-controlled systems.

Salary

The hourly rate for this position is $45 $47/hr on W2, depending on experience and qualifications.

Benefits

Eligible employees may have access to benefits in accordance with the applicable benefit plans and eligibility requirements.

Equal Opportunity Employer

We are an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Background Check

Background checks may be conducted in accordance with applicable law.

Work Authorization

Applicants must be authorized to work in the United States.