| Location | NULL, OH |
| Salary | $40–$45 Per Hour |
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.