GxP Sr. Systems Engineer

BioSpace; United States; On-site; USD 122,000 - 195,000; Full time

Benefits offered by this job

Competitive healthcare

Well-being programs

Family planning benefits

Generous paid time off

Savings and investments

Location-specific perks

Job summary

Moderna seeks a Senior Manager to lead the delivery and administration of Chromeleon CDS across Quality labs. You will configure, deploy, and validate systems, author test protocols, and ensure data integrity while coordinating with Infrastructure and QC teams.

Role includes on-site work with potential travel, supporting audits, change control, and continuous improvement of Chromeleon workflows within a GMP biopharma setting.

Qualifications

• 10 years’ experience supporting implementation or validation of laboratory informatics systems (SDMS, LIMS, ELN, CDS) within a biopharmaceutical GMP environment.
• Experience with GxP validation methodologies including GAMP 5, 21 CFR Part 11, Annex 11, and data integrity regulations.
• Experience supporting system upgrades or version migrations in regulated environments.
• Experience contributing to change control and qualification documentation (IQ/OQ/PQ/UAT).
• Understanding of laboratory instrument integration and digital laboratory workflows.
• Experience working with cloud-hosted or hybrid digital systems preferred.

Responsibilities

• Administer, configure, and maintain Chromeleon CDS across Moderna Quality labs.
• Support the implementation of the Chromeleon v7.3.2 CDS upgrade including infrastructure updates and instrument client upgrades.
• Execute validation activities in accordance with validated plans, including protocol execution and documentation.
• Assist with server upgrade validation activities in coordination with Infrastructure and Validation teams.
• Support change control, SOP updates, work instructions, and qualification documentation as required.
• Participate in regression testing and system verification post-upgrade.
• Ensure data integrity controls (ALCOA+) are maintained during upgrade, configuration, and validation activities.
• Partner with Digital and QC stakeholders to support issue resolution, UAT, and post-deployment stabilization.
• Maintain inspection readiness through adherence to quality policies and training requirements.
• Participate in audit support for Chromeleon-related documentation and system controls.
• Identify opportunities to optimize Chromeleon workflows and system performance.
• On-site presence is required with possible travel between regional sites.

Skills

Chromeleon CDS

GxP validation

Laboratory informatics

Change control

Validation documentation

Cloud/hybrid systems

Tools

Chromeleon CDS

Job description

The Role

Moderna is seeking a Sr. Manager who will serve a key role supporting the delivery and administration of laboratory systems. The individual will assist in configuration and deployment of systems, participate in generating and maintaining necessary procedure. Activities will also include authoring and executing test protocols.

Here’s What You’ll Do

• Administer, configure, and maintain Chromeleon CDS across Moderna Quality labs.
• Support the implementation of the Chromeleon v7.3.2 CDS upgrade including participation in infrastructure updates, application deployment activities, and instrument client upgrades.
• Execute validation activities in accordance with approved validation plans, including protocol execution, test script development, traceability support, and documentation compilation.
• Assist with server upgrade validation activities in coordination with Infrastructure and Validation teams.
• Support change control (CC), SOP updates, work instructions, and qualification documentation as required.
• Participate in regression testing and system verification to ensure Chromeleon functionality and instrument integrations perform as intended post-upgrade.
• Ensure data integrity controls (ALCOA+) are maintained during upgrade, configuration, and validation activities.
• Partner with Digital and QC stakeholders to support issue resolution, user acceptance testing (UAT), and post-deployment stabilization.
• Maintain inspection readiness through adherence to internal quality policies, procedures, and training requirements.
• Participate in audit support activities as a subject matter contributor for Chromeleon-related documentation and system controls.
• Apply a continuous improvement mindset to identify opportunities to optimize Chromeleon workflows and system performance.
• On-site presence is required with possible travel between regional sites.
• Additional duties may be assigned from time to time.

Here’s What You’ll Need (Minimum Qualifications)

• 10 years’ experience supporting implementation or validation of laboratory informatics systems (SDMS, LIMS, ELN, CDS) within a biopharmaceutical GMP environment.
• Experience with GxP validation methodologies including GAMP 5, 21 CFR Part 11, Annex 11, and data integrity regulations.
• Experience supporting system upgrades or version migrations in regulated environments.
• Experience contributing to change control and qualification documentation (IQ/OQ/PQ/UAT).
• Understanding of laboratory instrument integration and digital laboratory workflows.
• Experience working with cloud-hosted or hybrid digital systems preferred.

Here’s What You’ll Bring to the Table (Preferred Qualifications)

• Strong attention to detail and documentation rigor.
• Ability to execute validation activities within defined timelines and governance structures.
• Foundational understanding of laboratory data management systems and instrument connectivity.
• Strong interpersonal skills with the ability to collaborate effectively across Digital, QC, Infrastructure, and Validation teams.
• Ability to manage multiple concurrent tasks in a fast-paced GMP environment.
• Ability to effectively collaborate in a dynamic, cross-functional matrix environment.
• A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

Pay & Benefits

At Moderna, we believe that when you feel your best, you can do your best work. That’s why our benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.

• Competitive healthcare, 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 investments to help you plan for the future
• Location-specific perks and extras

The salary range for this role is $121,600.00 - $194,500.00(for positions that may be performed in California, the expected salary range is $144,150.00 - $165,850.00, which reflects the range permitted under California Labor Code requirements) . This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. 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.

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

Our Working Model

As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact.

Moderna is a smoke-free, alcohol-free, and drug-free work environment.

Equal Opportunities

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Accommodations

We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at [e-mail].

Export Control Notice This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant’s ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license.