Manufacturing Quality Engineering and 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

Job Description

The Quality Engineering and Validation Consultant is recognized as an expert internally in the principles and application of quality assurance and compliance. This position coordinates GMP activities in support of clinical and commercial Drug Product manufacture. This position reports to Associate Director GMP Quality - Cell & Gene. This is an onsite Monday through Friday position.

Responsibilities

• As part of the VCGT GMP Operational Quality group primarily responsible with providing quality oversight and support to Vertex Cell and Gene Therapy operations and capital projects in the following key areas/activities; support of manufacturing operations across all phases of development and commercial, support of validation, analytical laboratory, materials management, and facility/engineering groups.


• Provide QA support of change controls, validation protocols, risk assessments, GMP investigations and CAPAs.


• Responsible for identifying risks and communicating gaps for GMP process/systems


• Provide Quality oversight and review of calibrations, PMs, eCRs, work orders and laboratory operations via instrument qualifications


• Review and approval of trending programs (equipment, facility, utilities, etc.)


• Support EM and Routine testing of facilities and utilities and control programs (Client/EMS, pest control, etc.)

Requirements

• Experience providing QA support and oversight of GMP manufacturing operations and capital projects


• Aseptic processing


• Experience successfully leading event investigations, Root Cause Analysis and CAPA


• Experience with network-based applications such as Veeva, Nuvolo, Viewlinc


• Master's degree with 3-5 years of relevant work experience, or bachelor's degree in engineering, scientific or allied health field with minimum 8 years of relevant work experience, or relevant comparable background.

Key Leadership Skills

• Collaboration / Teamwork / Conflict Management


• Results Driver


• Key Knowledge/ Skills and Competencies


• The ability to thrive in a high throughput environment


• Foster cross-departmental collaboration within project teams to ensure alignment and timely resolution of issues.


• Ability to independently collaborate on cross-functional teams and represent the Quality unit


• Ability to communicate effectively across all organizational levels


• Critical Thinking / Problem Solving


• Ability to evaluate quality matters and make decisions utilizing risk-based approach


• Attention to detail