Characterization Consultant – CQV / Validation

Job Title: Characterization Consultant CQV / Validation
Company: Intellectt Inc
Location: New Albany, Ohio
Pay:$46 $48/hr W2
Work Environment:Onsite

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

Name: Soundarya Kondra
Email:

soundarya.kondra@intellectt.com

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

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