GxP Operations & MES Support Specialist

Vertex Pharmaceuticals LLC; Boston (MA); On-site; USD 52,000 - 79,000; Full time

Benefits offered by this job

Annual bonus

Annual equity awards

Job summary

Vertex is seeking a GxP Operations Support Specialist to assist in implementing and maintaining digital manufacturing systems. You will work with Manufacturing, Quality, Engineering, and IT to document processes and support system changes.

This on-site role emphasizes GMP/GxP compliance, incident monitoring, UAT support, and training materials. The position requires a bachelor’s or equivalent, and about 1 year of GMP/pharma experience.

Qualifications

• Bachelor's degree or high school diploma with pharma/biotech manufacturing experience.
• Typically requires 1 year of GMP pharma/biopharma industry experience.

Responsibilities

• Configure, test, and deploy MES changes under guidance from senior team members and system owners.
• Participate in workshops with Manufacturing, Quality, Engineering, Supply Chain, and IT.
• Support UAT, including test cases, results, defects, and resolution tracking.
• Assist with documentation, including requirements, test evidence, and change-control records.
• Support operational activities: monitor incidents, document issues, escalate concerns, coordinate with support teams.
• Maintain system and process documentation: SOPs, work instructions, training materials, maps.
• Assist end-user communications and MES release training.
• Analyze basic data to identify trends and support continuous improvement.
• Develop understanding of manufacturing operations, eBR, GxP, and MES best practices.

Skills

Attention to detail

Problem-solving

Analytical thinking

Documentation

Cross-functional collaboration

Communication

Education

Bachelor's degree or high school diploma with pharma experience

Job description

Vertex is seeking a GxP Operations Support Specialist to assist in implementing and maintaining digital manufacturing systems. You will work with Manufacturing, Quality, Engineering, and IT to document processes and support system changes.

This on-site role emphasizes GMP/GxP compliance, incident monitoring, UAT support, and training materials. The position requires a bachelor’s or equivalent, and about 1 year of GMP/pharma experience.