GxP MES Operations Specialist

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

Benefits offered by this job

On-site work five days a week

Total Rewards benefits

Job summary

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

The role involves configuring MES changes, supporting UAT, documenting test results, and maintaining SOPs while collaborating with cross-functional teams. On-site five days weekly with Vertex Total Rewards benefits are offered.

Qualifications

• Bachelor’s degree or higher in a related field or equivalent experience.
• 1 year of GMP/biopharma industry experience recommended.

Responsibilities

• Configure, test, and deploy MES and related system changes under guidance.
• Participate in cross-functional workshops with manufacturing, QA, engineering, and IT.
• Support UAT with test cases, results, defects, and issue resolution.
• Assist with documentation including requirements and change-control records.
• Monitor incidents and coordinate with support teams for operations.
• Maintain system and business-process documentation and SOPs.
• Coordinate end-user communications and training on MES releases.
• Analyze system data to identify trends and drive improvements.
• Develop understanding of electronic batch records and GMP requirements.

Skills

Documentation

Analytical thinking

Cross-functional collaboration

GxP knowledge

Regulatory compliance

Learning agility

Education

Bachelor’s degree or equivalent experience

Job description

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

The role involves configuring MES changes, supporting UAT, documenting test results, and maintaining SOPs while collaborating with cross-functional teams. On-site five days weekly with Vertex Total Rewards benefits are offered.