Manufacturing Engineer

Job Title: Manufacturing Engineer

Company: Novozen Health Care

Location: Cincinnati, Ohio

Employment Type: Contract (1 Year+)

Job Responsibilities

• Support equipment and process characterization activities within a pharmaceutical manufacturing environment, focusing on assembly and packaging equipment.

• Develop, execute, and generate characterization protocols, technical reports, and supporting documentation.

• Evaluate equipment functionality and performance against User Requirement Specifications (URSs) to verify design intent and operational requirements.

• Perform troubleshooting, root cause analysis, and investigations into equipment deficiencies, process failures, and unexpected results.

• Conduct process characterization studies, including Design of Experiments (DOE), engineering runs, parameter mapping, sampling studies, and statistical analysis.

• Support commissioning, equipment qualification, startup activities, and equipment readiness assessments.

• Analyze study data, document findings, and develop technical recommendations based on characterization outcomes.

• Collaborate with Engineering, Validation, Quality, and Manufacturing teams to resolve technical issues and ensure compliance with applicable quality and regulatory requirements.

Required Qualifications

• Experience in equipment and process characterization within a pharmaceutical or regulated manufacturing environment.

• Hands-on experience with protocol development, execution, documentation, and technical report generation.

• Knowledge of Design of Experiments (DOE), engineering runs, parameter mapping, sampling studies, and statistical analysis.

• Strong troubleshooting and root cause analysis skills related to equipment performance and process failures.

• Ability to evaluate equipment performance against User Requirement Specifications (URSs).

• Experience with technical documentation, data analysis, and investigation of unexpected results.

• Experience supporting commissioning, equipment qualification, or startup activities is highly desirable.

• Direct experience with assembly or packaging equipment is a strong plus.

• Prior pharmaceutical manufacturing and Good Manufacturing Practice (GMP) experience is preferred.

• Strong communication and collaboration skills to work effectively with cross-functional teams.

Pay Scale:
Anticipated hourly pay range$40 $44 per hour on W-2.
Benefits:
Employees hired into this position are eligible for the following benefits, subject to the 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 other than that required by applicable state and local laws.