GMP Quality Engineer & Validation Consultant

Katalyst CRO; Boston (MA); On-site; USD 120,000 - 180,000; Full time

Job summary

Katalyst CRO is seeking a Quality Engineering and Validation Consultant to coordinate GMP activities for Cell & Gene Therapy operations. This onsite role reports to the GMP Quality group and supports clinical and commercial Drug Product manufacture.

The candidate will lead QA oversight of calibration programs, change controls, investigations and CAPAs, while collaborating across facilities, engineering, and analytical labs to ensure high-quality, compliant results.

Qualifications

• Experience providing QA support and oversight of GMP manufacturing operations and capital projects.
• Aseptic processing experience.
• Experience leading event investigations, Root Cause Analysis and CAPA.
• Experience with Veeva, Nuvolo, Viewlinc.

Responsibilities

• Provide QA support and oversight for GMP manufacturing operations and capital projects.
• Support validation, analytical, facilities and engineering groups.
• Review and approve change controls, validation protocols, risk assessments, investigations and CAPAs.
• Review calibrations, PMs, eCRs, and laboratory operations.
• Assist in trending programs for equipment, facilities and utilities.

Skills

QA oversight

GMP compliance

Aseptic processing

Root Cause Analysis

CAPA

Risk assessment

Cross-functional collaboration

Communication

Problem Solving

Attention to detail

Education

Master's degree in engineering/science/health

Bachelor's degree in engineering/science/health

Tools

Veeva

Nuvolo

Viewlinc

Job description

Katalyst CRO is seeking a Quality Engineering and Validation Consultant to coordinate GMP activities for Cell & Gene Therapy operations. This onsite role reports to the GMP Quality group and supports clinical and commercial Drug Product manufacture.

The candidate will lead QA oversight of calibration programs, change controls, investigations and CAPAs, while collaborating across facilities, engineering, and analytical labs to ensure high-quality, compliant results.