Job Details

Job Description

GxP Systems Engineer – Digital Quality Systems(Assigned to Pushpit )

Location: Norwood & Marlborough, MA

Department: Digital Quality / GxP Digital Systems

Level: 6

Position Overview

Moderna is seeking a highly motivated and technically skilled GxP Systems Engineer to support the design, deployment, integration, and lifecycle management of advanced Digital Quality and laboratory automation systems within a GMP-regulated biopharmaceutical environment.

This role will focus on supporting first-in-kind automation platforms, analytical instrumentation, and connected digital laboratory systems that enable Quality Control operations and enterprise-wide digital integration initiatives. The ideal candidate will combine strong technical expertise with a passion for innovation, operational excellence, compliance, and continuous improvement.

The successful candidate will work cross-functionally with Digital, Quality, Automation, Validation, and Laboratory teams to ensure scalable, compliant, and reliable digital laboratory solutions.

Key Responsibilities

Digital Quality & System Engineering

Design, implement, configure, maintain, and optimize Digital Quality automation systems and analytical instrumentation within GMP laboratory environments.

Support the full lifecycle management of Digital Quality systems including:

Implementation

System optimization

Maintenance

Troubleshooting

Validation support

Version upgrades

Work with platforms and systems such as:

Hamilton Venus

Scitara DLX

Hamilton Liquid Handling Systems

SpectraMax M5

Connected laboratory instrumentation

System Integration & Digital Connectivity

Translate laboratory, business, and integration requirements into scalable digital lab solutions.

Support instrument integration and data connectivity between:

On-premise laboratory systems

Cloud/SaaS digital platforms

Enterprise data ecosystems

Partner with Digital and Automation teams to support:

Connected instrument pipelines

Robotics and automation initiatives

AI-enabled laboratory capabilities

Digital workflow optimization

Compliance & Validation

Ensure all systems comply with:

GxP regulations

GMP requirements

Data integrity standards

GAMP guidelines

Support and maintain validation and compliance documentation including:

SOPs

Work Instructions

Change Controls

Knowledge Base Articles

Lifecycle Documentation

Maintain inspection readiness and participate in internal/external audits as Digital Quality SME.

Continuous Improvement & Collaboration

Drive operational excellence initiatives and identify opportunities to improve laboratory digital workflows and system performance.

Foster innovation by leveraging emerging technologies and creative solutions.

Collaborate effectively within cross-functional and matrixed teams across Digital, Quality, Manufacturing, Validation, and Laboratory Operations.

Provide technical guidance and troubleshooting support to stakeholders and end users.

Required Qualifications

Bachelor's Degree in:

Engineering

Computer Science

Life Sciences

Related Technical Discipline

5–7+ years of experience supporting analytical instrumentation and laboratory digital systems in a GMP-regulated biopharmaceutical environment.

Hands-on experience with:

Laboratory automation systems

Instrument integration

Laboratory digital workflows

GxP-compliant systems

Experience with:

GAMP

GMP

Data Integrity regulations

Change control processes

Understanding of cloud-hosted Digital systems and connectivity between on-premise and SaaS/Cloud platforms.

Strong troubleshooting and systems integration experience.

Preferred Qualifications

Direct experience with:

Hamilton Venus

Scitara DLX

Hamilton Liquid Pipetting Systems

SpectraMax M5

Experience with Linux Ubuntu and SUDO commands.

Familiarity with:

Robotics integration

AI-enabled laboratory systems

Connected laboratory ecosystems

Strong understanding of:

Laboratory Quality Management workflows

Digital Quality systems

Instrument data integration

Desired Skills & Competencies

Strong analytical and problem-solving abilities.

Innovative mindset with passion for continuous improvement.

Excellent communication and interpersonal skills.

Ability to work independently and manage multiple concurrent projects.

Strong collaboration skills within dynamic cross-functional teams.

Ability to thrive in a fast-paced, evolving environment.

Strong organizational and documentation skills.

Customer-focused and quality-driven mindset.