CQV / Equipment Characterization Consultant – Pharmaceutical Manufacturing

Tek Support; New Albany (OH); On-site; USD 90,000 - 130,000; Full time

Job summary

Tek Support seeks a CQV/Validation Consultant to support equipment and process characterization for pharmaceutical assembly and packaging equipment.

You will develop and execute characterization protocols, perform DOE and data analysis, and collaborate with Engineering, Validation, Quality, and Manufacturing to ensure equipment readiness and compliant documentation.

Qualifications

• Characterization of equipment and processes required for qualification activities.
• Experience with DOE and statistical methods to analyze data.
• Strong root-cause analysis and troubleshooting abilities.
• Background in GMP/pharmaceutical manufacturing environments.
• Experience with assembly or packaging equipment preferred.

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.

Skills

Equipment/Process characterization

DOE / statistical analysis

Root cause analysis & troubleshooting

GMP/pharmaceutical manufacturing

Assembly or packaging equipment

Job description

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
• DOE / statistical analysis
• Root cause analysis & troubleshooting
• GMP/pharmaceutical manufacturing experience
• Assembly or packaging equipment experience preferred

Eligible employees may have access to benefits offered by Teksupport in accordance with the applicable benefit plans and eligibility requirements.

Tek Support 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.