Sr. Engineer I, 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 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. May telecommute up to 2 days per week. The salary range for this role is $121,600 to $194,500. This range reflects the lowest to highest salary we, in good faith, believe we would pay for this role at the time of this posting. The minimum target pay for this particular position, based on its primary location, is $148,600 to $194,500. An individual's placement within the range will depend on several factors, including but not limited to specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs.

Apply at https:

//modernatx.wd1.myworkdayjobs.com/en-US/M_tx (

Job ID:

R19156) or email resume and cover letter to careers@modernatx.

com with subject line:

R19156 Pay & Benefits At Moderna, we believe that when you feel your best, you can do your best work. That's why our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between. 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 The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance. #DNI Pay & Benefits At Moderna, we believe that when you feel your best, you can do your best work. That's why our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between. 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 The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance. Our Mission and Vision At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body's cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells. We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission.

Our Mission:

To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients.

Our Vision:

To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today. Third Party Staffing Agencies Moderna does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes. Reasonable Accommodation Notice Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. Please inform the company's personnel representative by calling 617-460-9346 or emailing humanresources@modernatx.com if you need assistance completing any forms or to otherwise participate in the application process. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment. Return Home