Manufacturing Quality Engineering and Validation Consultant

Creative Solutions Services, LLC; Boston (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a Quality Engineering and Validation Consultant to provide expert QA oversight for GMP activities supporting clinical and commercial Drug Product manufacture. This onsite role reports to the Associate Director GMP Quality - Cell & Gene and operates Monday through Friday.

You will lead change controls, validation activities, CAPAs, and risk assessments, ensuring compliance across manufacturing, analytics, materials, and facilities.

Qualifications

• Experience providing QA support and GMP manufacturing oversight.
• Experience leading event investigations and CAPA.
• Strong knowledge of validation, change controls, and risk-based decision making.

Responsibilities

• Provide QA oversight of GMP manufacturing operations and capital projects across development and commercial phases.
• Lead change controls, validation protocols, risk assessments, GMP investigations and CAPAs.
• Identify risks and communicate gaps in GMP processes and systems to drive improvement.
• Review calibrations, PMs, eCRs, work orders and laboratory operations for quality and compliance.
• Support facilities, utilities, and control programs through trending and investigations.

Skills

QA oversight

Aseptic processing

CAPA & investigations

Risk assessment

Validation protocols

Cross-functional collaboration

Quality system knowledge

Education

Master's degree with 3-5 years relevant work experience

Bachelor's degree in engineering/science/health field with 8+ years relevant experience

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