MES & GxP Operations Specialist

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

Job summary

Vertex Pharmaceuticals seeks a GxP Operations Support Specialist to help implement, test, and maintain digital manufacturing systems, with a focus on MES configurations and change control. You will collaborate with Manufacturing, Quality, Engineering, and IT to document processes and ensure compliant operations.

Responsibilities include supporting UAT, incident monitoring, and creating SOPs, work instructions, and training materials.

Qualifications

• Attention to detail in documentation and processes.
• Demonstrated problem-solving and analytical skills.
• Ability to learn new technologies in a fast-paced environment.
• Experience in cross-functional collaboration and communication.
• Familiarity with GMP, GxP, data integrity, and computer system validation.

Responsibilities

• Help configure, test, and deploy MES and other system changes.
• Support user acceptance testing (UAT) with test cases and defect tracking.
• Assist with documentation, change-control records, and SOPs.
• Monitor incidents and coordinate with support teams for resolution.
• Develop training materials and communicate system enhancements.

Skills

Detail-oriented

Problem-solving

Communication skills

Cross-functional teamwork

Adaptability

Education

Bachelor’s degree or equivalent

Job description

Vertex Pharmaceuticals seeks a GxP Operations Support Specialist to help implement, test, and maintain digital manufacturing systems, with a focus on MES configurations and change control. You will collaborate with Manufacturing, Quality, Engineering, and IT to document processes and ensure compliant operations.

Responsibilities include supporting UAT, incident monitoring, and creating SOPs, work instructions, and training materials.