Characterization Consultant Cqv Validation

Job Description:
Our client, Amgen, is seeking Characterization Consultants to support equipment and process characterization activities at its pharmaceutical manufacturing facility in New Albany, Ohio. The role focuses on assembly and packaging equipment, equipment performance assessment, troubleshooting, and validation support within a regulated GMP environment.

The consultant will develop and execute characterization protocols, evaluate equipment functionality against User Requirement Specifications (URS), perform root cause analysis, analyze study data, and prepare technical reports. The role also involves supporting commissioning, equipment startup, and collaboration with Engineering, CQV, Validation, Quality, and Manufacturing teams.


Key Responsibilities:

Develop, execute, and document equipment and process characterization protocols.

Evaluate assembly and packaging equipment against URS and design requirements.

Perform Design of Experiments (DOE), engineering runs, parameter mapping, and sampling studies.

Troubleshoot equipment and process issues and conduct root cause analysis.

Analyze data, investigate unexpected results, and recommend corrective actions.

Support commissioning, equipment qualification, and equipment readiness activities.

Prepare technical reports and GMP-compliant documentation.

Collaborate with Engineering, CQV, Validation, Quality, and Manufacturing teams.


Required Skills:

Experience in pharmaceutical or biotech manufacturing.

Background in CQV, equipment validation, process validation, equipment engineering, or process characterization.

Knowledge of GMP documentation, URS, protocol execution, and technical reporting.

Strong troubleshooting and root cause analysis skills.

Experience with equipment characterization, engineering studies, or process performance evaluation.

Benefits: Eligible employees may have access to benefits offered by Intellectt Inc. in accordance with the applicable benefit plans 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.

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