Sr. Engineer, GxP Systems

JOB DESCRIPTION

Title:                    Sr. Engineer, GxP Systems

Reports to:        Director, Product Management

Function:            Digital

Location:            Norwood, MA

The Role:

ModernaTX, Inc. seeks a Sr. Engineer, GxP Systems for its Norwood, Massachusetts location.

Here’s What You’ll Do:

• Design, deployment, validation and management for digital enterprise instrumentation systems.

• Collaborate with business analysts and software/automation engineers in the complete product lifecycle management of various digital quality enterprise and laboratory instrumentation systems including the Chromatography Data System (Chromeleon), Scientific Data Management System (LogiLab SDMS), and data acquisition and analysis software for microplate readers (SoftMax Pro).

• Ensure all validated laboratory systems comply with FDA 21 CFR Part 11, GAMP 5, and USP 1058 Analytical Instrument Qualification (AIQ) requirements.

• Translate system, equipment, and data integration requirements from digital and business teams for deployment into the appropriate digital lab system solution.

• Manage system change controls and configuration updates and validate changes, ensuring that laboratory systems comply with regulatory and industry best practices.

• Ensure successful validation and integration of key systems into the connected instrument pipeline, robotics/automation capabilities and artificial intelligence initiatives.

• Support periodic system reviews, revalidation efforts, and version upgrades to maintain the validated state and operational efficiency.

• Ensure good manufacturing practices (GMP) compliance is built into the design, delivery, and maintenance of all systems.

• Conduct Computer System Validation (CSV) activities by developing and executing SDLC qualification protocols and writing system configuration specifications, risk assessments, and administration procedures.

• Resolve production issues.

• Implement and enforce data integrity principles across laboratory systems, ensuring compliance with Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available (ALCOA+) guidelines.

• Participate in internal and external audits as digital quality expert for a portfolio of systems.

• Implement automated file transfer solutions to support seamless data movement and ensure data integrity, in alignment with evolving business needs.

• Author, review, and maintain Standard Operating Procedures (SOPs), Work Instructions, Change Control Documents, and Training Materials for all laboratory systems.

• Facilitate Deviations, Investigation, Corrective and Preventive Actions (CAPA) of laboratory system issues or non-conformities.

• Support resolving Good Practices (GxP) compliance issues through root cause analysis, remediation plans, and preventive measures.

• Assess server and database requirements and work cross-functionally with Network, Cloud, Cybersecurity, and Database teams to complete the enterprise system multi-site extension.

• Ensure infrastructure design aligns with system requirements, to support seamless connectivity and enterprise-wide accessibility.

• Enterprise System Design and Configuration and Deployment of Infrastructure, ensuring proper system architecture and optimized performance for multi-site operations.

• Identify and implement new digital solutions, including automation and artificial intelligence (AI), that drive continuous improvement, enhance laboratory efficiency, ensure data integrity, and strengthen compliance tracking.

• Participate in improvement initiatives such as CAPA effectiveness reviews, risk assessments, and process optimizations to support sustained operational excellence in a GxP environment.

Here’s What You’ll Bring to the Table:

Minimum Requirements:

• Requires a Master’s degree, or foreign equivalent, in Engineering (any), Computer Science, or related field and 3 years of experience as a Validation Engineer, System Engineer, or related position supporting computer systems validation.

• In the alternative, employer will accept a Bachelor’s degree, or foreign equivalent, in the specified fields and 5 years of the specified progressive, post-baccalaureate experience.

• 3 years of experience must include:

  • Computer System Validation using IQ/OQ/PQ protocols;

  • Ensuring ALCOA+ data integrity & regulatory compliance;

  • Assessing system requirements, configuring ne