Process&Equipment Characterization Engineer

Job Title: Process & Equipment Characterization Engineer
Company:Novozen
Location: Ohio, USA
Employment Type: Contract (W2)

Job Summary:
We are seeking a Process & Equipment Characterization Engineer to support process optimization, equipment characterization, and qualification activities in a regulated pharmaceutical and medical device manufacturing environment. The ideal candidate will have hands-on experience with DOE, Minitab, statistical analysis, and automated assembly or packaging equipment.

Key Responsibilities:

• Design and execute DOE studies, engineering runs, parameter mapping, and sampling studies to establish process windows.

• Analyze data using Minitab, Cp/Cpk, SPC, and MSA/Gage R&R to evaluate process capability and variation.

• Author and execute IQ/OQ/PQ and characterization protocols in accordance with GMP requirements.

• Troubleshoot equipment and process issues and lead root cause investigations.

• Evaluate equipment against URS requirements and support commissioning, installation, and startup activities.

• Develop and update PFMEAs, Control Plans, and technical reports.

• Collaborate with Engineering, Validation, Quality, Automation, and Manufacturing teams.

Required Qualifications:

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

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

• Knowledge of Minitab, Cp/Cpk, SPC, and MSA/Gage R&R.

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

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

• Familiarity with GMP, FDA regulations, and ISO 13485.

• Direct assembly or packaging equipment experience preferred.

• Ability to work on-site in Ohio.

Pay Scale:

• Anticipated hourly pay range {$40-$45/hr on W2}

Benefits:

Employees hired into this position are eligible for the following benefits, subject to applicable plan terms and eligibility requirements:

Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.

Retirement Benefits: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.

Paid Time Off (PTO): No PTO is provided other than that required by applicable state and local laws.