GXP Systems Engineer, Digital Quality & Automation

Career Soft Solutions Inc; Marlborough (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

Moderna is seeking a GxP Systems Engineer to design, deploy, and manage automation systems that support Quality Control GMP laboratories. This role involves collaborating with teams to ensure compliance with regulatory documentation and system integration. The candidate should have a Bachelor’s degree and 5-7 years of experience in life sciences within a GMP environment.

The position requires on-site presence and may involve travel. The ideal candidate will foster innovation and maintain inspection readiness while participating in audits.

Qualifications

• 5 to 7+ years’ experience in biopharmaceutical GMP environments.
• Experience with automation solutions preferred.
• Knowledge of data integrity regulations and instrument integration.

Responsibilities

• Manage product lifecycle of Digital Quality Automation Systems.
• Ensure successful validation and integration of systems.
• Maintain inspection readiness for audits.

Skills

Designing life sciences Analytical Instruments

Implementing automation solutions

Managing laboratory digital workflows

Understanding GxP compliance regulations

Collaborative problem solving

Education

Bachelor’s degree in science, engineering or computer science

Tools

Hamilton Venus

Linux Ubuntu

Job description

Moderna is seeking a GxP Systems Engineer to design, deploy, and manage automation systems that support Quality Control GMP laboratories. This role involves collaborating with teams to ensure compliance with regulatory documentation and system integration. The candidate should have a Bachelor’s degree and 5-7 years of experience in life sciences within a GMP environment.

The position requires on-site presence and may involve travel. The ideal candidate will foster innovation and maintain inspection readiness while participating in audits.