GxP Systems & MES Operations Specialist

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

Benefits offered by this job

Annual bonus

Annual equity awards

Comprehensive benefits

Job summary

Vertex Pharmaceuticals Incorporated is seeking a GxP Operations Support Specialist to help implement and maintain digital manufacturing systems. You will work with Manufacturing, Quality, Engineering, and IT to document processes, test changes, and ensure compliant operations.

You will help configure MES and support end-to-end system releases, user training, and change-control activities, while building a deep understanding of manufacturing operations and data integrity requirements.

Qualifications

• Bachelor's degree or equivalent with pharmaceutical/biotech exposure or equivalent experience.
• Familiarity with GMP/GxP, data integrity, and validation concepts is preferred.
• Experience in documenting requirements, test evidence, and change-control records.

Responsibilities

• Configure, test, and deploy MES and related system changes under supervision.
• Support UAT, create test cases, track defects, and coordinate fixes.
• Maintain system documentation, SOPs, work instructions, and process maps.
• Assist with incident monitoring, issue escalation, and collaboration with support teams.
• Analyze data to identify trends and aid continuous improvement initiatives.

Skills

Attention to detail

Problem solving

Analytical thinking

Communication skills

Learning new tech

Cross-functional collaboration

Education

Bachelor's degree or equivalent in related field

Tools

MES

Document control tools

Job description

Vertex Pharmaceuticals Incorporated is seeking a GxP Operations Support Specialist to help implement and maintain digital manufacturing systems. You will work with Manufacturing, Quality, Engineering, and IT to document processes, test changes, and ensure compliant operations.

You will help configure MES and support end-to-end system releases, user training, and change-control activities, while building a deep understanding of manufacturing operations and data integrity requirements.