Characterization Consultant – CQV / Validation

Role: Characterization Consultant CQV / Validation
Location: New Albany, Ohio
Company: Intellectt Inc
Duration: 12+ Months
Start: Nov 2 or Nov 16
Shift: 2nd/3rd
Rate: $46 $48/hr W2

Job Summary:
Seeking a CQV/Validation Consultant to support equipment and process characterization for pharmaceutical assembly and packaging equipment.

Key Responsibilities:

• Develop and execute characterization protocols.
• Perform equipment/process characterization and engineering runs.
• Challenge equipment against URS and design requirements.
• Conduct DOE, parameter mapping, sampling studies, and statistical analysis.
• Troubleshoot equipment/process issues and perform RCA.
• Support commissioning, qualification, and equipment readiness.
• Prepare technical reports and characterization documentation.
• Collaborate with Engineering, Validation, Quality, and Manufacturing teams.

Required Skills:

• Equipment/process characterization
• Protocol development & execution
• DOE / statistical analysis
• Root cause analysis & troubleshooting
• URS/design documentation
• Commissioning / equipment qualification
• GMP/pharmaceutical manufacturing experience
• Assembly or packaging equipment experience preferred

Contact to Apply:
Name: Uzma Kousar Mohammed
Email:

uzma.kousar@intellectt.com

Equal Employment Opportunity:
Intellectt Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.
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