CQV Engineer

United Pharma; New York (NY); On-site; USD 90,000 - 150,000; Full time

Job summary

United Pharma in New York seeks a CQV Engineer to support commissioning, qualification, and validation for column packing and downstream processing equipment. You will review design deliverables and develop CQV documentation, assisting installation, startup, and qualification.

You will review vendor documents, participate in FAT/SAT/IOQ activities, and coordinate with Engineering, Manufacturing, Quality, and vendors to resolve issues per GMP standards.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
• Extensive experience in CQV, validation, commissioning, or qualification within pharmaceutical or biotechnology environments.
• Hands-on experience with column packing activities in large-scale GMP manufacturing facilities.
• Experience with chromatography systems and downstream processing equipment.
• Strong understanding of GMP regulations and equipment qualification methodologies.
• Experience with FAT, SAT, IOQ, risk assessments, and validation lifecycle documentation.
• Strong technical documentation, troubleshooting, and cross-functional coordination skills.

Responsibilities

• Support CQV activities for column packing systems and downstream processing equipment.
• Review engineering drawings, datasheets, equipment specifications, vendor documents, and design packages.
• Develop, review, and execute CQV lifecycle documentation, including DQ, RTM, QRA, FAT, SAT, IOC, IOQ, and final reports.
• Support commissioning, startup, and qualification of chromatography and column packing systems.
• Participate in vendor package reviews and technical assessments of downstream processing equipment.
• Coordinate with Engineering, Manufacturing, Quality, and equipment vendors to resolve technical issues.
• Ensure qualification activities comply with GMP requirements and project standards.

Skills

CQV

Validation

Commissioning

Documentation

GMP knowledge

Cross-functional coordination

Chromatography

Education

Bachelor's degree in Engineering/Life Sciences

Job description

The CQV Engineer will support commissioning, qualification, and validation activities for column packing systems and associated downstream processing equipment. The role involves reviewing engineering design deliverables, developing and executing CQV documentation, and supporting equipment installation, startup, and qualification.

Key Responsibilities:

• Support CQV activities for column packing systems and downstream processing equipment.
• Review engineering drawings, datasheets, equipment specifications, vendor documents, and design packages.
• Develop, review, and execute CQV lifecycle documentation, including DQ, RTM, QRA, FAT, SAT, IOC, IOQ, and final reports.
• Support commissioning, startup, and qualification of chromatography and column packing systems.
• Participate in vendor package reviews and technical assessments of downstream processing equipment.
• Coordinate with Engineering, Manufacturing, Quality, and equipment vendors to resolve technical issues.
• Ensure qualification activities comply with GMP requirements and project standards.

Skills & Qualifications:

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
• Extensive experience in CQV, validation, commissioning, or qualification within pharmaceutical or biotechnology environments.
• Hands-on experience with column packing activities in large-scale GMP manufacturing facilities.
• Experience with chromatography systems and downstream processing equipment.
• Strong understanding of GMP regulations and equipment qualification methodologies.
• Experience with FAT, SAT, IOQ, risk assessments, and validation lifecycle documentation.
• Strong technical documentation, troubleshooting, and cross-functional coordination skills.