Sr. Engineer I, GxP Systems

ModernaTX • Norwood, MA

5d • Hybrid

About The Position

ModernaTX, Inc. seeks a Sr. Engineer, GxP Systems for its Norwood, Massachusetts location. This role involves the design, deployment, validation, and management of digital enterprise instrumentation systems. The engineer will collaborate with business analysts and software/automation engineers throughout the product lifecycle of various digital quality enterprise and laboratory instrumentation systems, including specific systems like Chromeleon, LogiLab SDMS, and SoftMax Pro. A key aspect of the role is ensuring compliance with FDA 21 CFR Part 11, GAMP 5, and USP 1058 AIQ requirements. The position also requires translating system requirements, managing change controls, validating changes, and ensuring successful integration of systems into advanced pipelines like robotics, automation, and AI initiatives. Support for periodic reviews, revalidation, and upgrades is also expected, alongside building Good Manufacturing Practices (GMP) compliance into system design and maintenance. The role includes conducting Computer System Validation (CSV) activities, resolving production issues, and enforcing data integrity principles according to ALCOA+ guidelines. Participation in audits, implementation of automated file transfers, and authoring/reviewing SOPs and related documentation are also core responsibilities. The engineer will facilitate deviation investigations and CAPA management, support GxP compliance issue resolution, and assess infrastructure requirements in collaboration with various IT teams to ensure seamless connectivity and accessibility. Identifying and implementing new digital solutions, including automation and AI, to drive continuous improvement and enhance laboratory efficiency is also a focus. The role involves participation in improvement initiatives such as CAPA effectiveness reviews and risk assessments.

Requirements

• 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.
• Alternatively, a Bachelor’s degree, or foreign equivalent, in the specified fields and 5 years of 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 network & security settings, and maintaining system stability & compliance for enterprise systems & infrastructure; System issue troubleshooting for laboratory instruments and systems; GxP Systems Administration and Compliance; Risk Management & FMEA (failure modes and effects analysis); GxP Records Management; and Root Cause Analysis and CAPA management for GxP deviation investigations.

Responsibilities

• 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.

Benefits

• Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
• Family planning benefits, including fertility, adoption, and surrogacy support
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investment opportunities to help you plan for the future
• Location-specific perks and extras
• Annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior