ATL02-062425 CQV Engineer – Fill/Finish and Analytical Equipment (PA) jobs in United States
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Validation & Engineering Group, Inc. · 3 weeks ago

ATL02-062425 CQV Engineer – Fill/Finish and Analytical Equipment (PA)

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier providing solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries. They are currently seeking a CQV Engineer with expertise in laboratory systems and aseptic fill/finish equipment to support commissioning and qualification activities in GMP operations.

BiotechnologyConsultingProfessional ServicesQuality Assurance

Responsibilities

Author, review, and execute risk-based qualification protocols (IQ, OQ, PQ) for:
QC modules: Flow Cytometry, Cell Count, Reagent Fill, Ambient and Cold Storage
Laboratory equipment: Biosafety cabinets, isolators, centrifuges, balances, peristaltic pumps, air samplers
Aseptic fill/finish systems: Vial filling modules, isolators, cappers, crimpers, inspection systems
Lead system walkdowns, protocol execution, and traceability matrix development
Coordinate FAT/SAT support and ensure test readiness for system turnover
Collaborate with automation, operations, and quality stakeholders to align timelines and mitigate issues
Support deviation documentation and protocol closure per project requirements

Qualification

CQV experienceQualification strategiesAseptic fill/finish systemsLaboratory systemsQC modulesTroubleshooting skillsDocumentation skillsCross-functional coordination

Required

Bachelor's degree in life sciences, engineering, or related field
Minimum 5 years of CQV experience in a GMP lab, QC, or aseptic fill/finish setting
Strong knowledge of qualification strategies for lab, QC, and drug product systems
Experience with barrier systems, inspection technologies, and integrated QC modules
Excellent documentation, troubleshooting, and cross-functional coordination skills

Company

Validation & Engineering Group, Inc.

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Validation & Engineering Group, Proudly serving our clients since 1997.

Funding

Current Stage
Growth Stage
Total Funding
unknown
2025-08-06Acquired

Leadership Team

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Luis Puig
Partner
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Company data provided by crunchbase