CQV Specialist: Biotech GMP Validation Expert (Onsite)

Intellectt INC; Minnesota; On-site; USD 70,000 - 95,000; Full time

Job summary

Intellectt INC is seeking an experienced CQV Specialist to support commissioning, qualification, and validation activities within a GMP biopharmaceutical manufacturing environment in Minnesota. The role focuses on qualification of upstream and fill-finish equipment, including bioreactors and CIP/SIP systems, to ensure compliant operations.

The ideal candidate has 10+ years of CQV/validation experience, strong hands-on IQ/OQ/PQ skills, and solid knowledge of GMP/cGMP, FDA requirements, CAPA, and

Qualifications

• 10+ years of CQV, Validation, Quality, or Engineering experience in pharma/biotech manufacturing.
• Strong hands-on IQ/OQ/PQ protocol authoring and validation reports.
• Experience supporting upstream vessels, bioreactors, and fill-finish lines.
• Experience with CIP/SIP, process transfer systems, and process utilities.
• Hands-on experience writing, investigating, and resolving deviations in GMP environments.
• Experience with commissioning, equipment startup, and qualification activities.
• Knowledge of GMP/cGMP, FDA requirements, CAPA, change control, and risk assessments.
• Strong technical writing, documentation, and cross-functional communication skills.
• Bachelor's degree in Engineering, Life Sciences, Biotechnology, or related technical discipline

Responsibilities

• Support commissioning, qualification, and validation activities within a GMP biopharmaceutical manufacturing environment.
• Focus on qualification of upstream and fill-finish equipment including bioreactors and CIP/SIP systems.

Skills

CQV experience

Validation

Technical writing

Cross-functional communication

GMP knowledge

Education

Bachelor's degree in Engineering/Life Sciences/Biotech

Job description

Intellectt INC is seeking an experienced CQV Specialist to support commissioning, qualification, and validation activities within a GMP biopharmaceutical manufacturing environment in Minnesota. The role focuses on qualification of upstream and fill-finish equipment, including bioreactors and CIP/SIP systems, to ensure compliant operations.

The ideal candidate has 10+ years of CQV/validation experience, strong hands-on IQ/OQ/PQ skills, and solid knowledge of GMP/cGMP, FDA requirements, CAPA, and