Moderna · 2 months ago
Engineer II, Validation
Norwood, Massachusetts
Full-time
Onsite
Entry, Mid Level
$72K/yr - $116K/yr
2+ years expModerna is a leading mRNA technology platform company focused on transforming medicine. The Engineer II, Validation role involves performing commissioning, qualification, and validation activities for the company's GMP manufacturing facility, ensuring compliance and operational readiness of systems and equipment.
BiotechnologyGeneticsHealth CareMedicalPharmaceuticalTherapeutics
No H1B
U.S. Citizen Only
Responsibilities
Perform commissioning, qualification, and validation activities for Moderna’s GMP manufacturing facility which includes raw material, Drug Substance, Formulation, Drug Product, Finished Goods, and personalized medicine capabilities
Working with external validation service providers. Responsibilities and ensure commitment to key stakeholders are met
Ensure the validated status of site facilities, utilities, equipment, and processes is established and maintained in accordance with internal procedures, regulatory requirements, and industry guidance / standards
Support new equipment qualification activities for capital and operational projects
Assist investigation and reviews deviation investigations related to manufacturing process equipment, utilities, automation, computer systems, validation, and laboratory instruments
Provide support for equipment and systems in use at Moderna facilities (Controlled Temperature Units [Refrigerators, Freezer, Incubators], Analytical Instruments [used for in-process and quality control testing], Manufacturing Unit Operations [Ultrafiltration, Chromatography, Mixers, Tanks / Vessels, Bioreactors / Fermenters], etc.)
Support internal and external audits/inspections as a part of Commissioning, Qualification and Validation program
Participate in continuous quality system improvements and supports implementing improvements in the GMP Validation and Change Control Programs
Drive results by owning and completing validation initiatives / projects against identified timelines
Own quality records such as Change Controls, Deviations, Corrective / Preventative Actions (CAPAs), and continuous improvement initiatives related to validation activities
Additional duties as may be assigned from time to time
Qualification
Required
B.S. in Life Science or Engineering Degree (Mechanical, Computer Science or Biomedical Engineering Etc.)
Minimum of 2+ years in commissioning / qualification / validation / quality experience in cGMP manufacturing environments
Strong understanding of validation principles including but not limited to facilities, utilities, equipment, and systems (FUSE)
Excellent technical documentation generation and review skills ensuring the content is technically sound, adheres to applicable site procedures and is suitable for regulatory submission / inspection
Must be able use his / her technical background to investigate issues using a structured problem-solving approach to determine true root cause and develop effective corrective and preventative actions
Must be able to find true root cause and path forward for complex problems
Excellent interpersonal and communication skills (verbal and written) are required
Expected to be able to present own work to peers and cross-functional managers and influence leadership decisions
Technical writing skills required
Ability to interact well with other groups and must be able to take ownership of and follow through on assignments
Must be able to drive results on multiple complex assignments simultaneously with minimal required direction from his / her manager
Ability to represent Moderna's interests, objectives, and policies in a professional and responsible manner
A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative
Candidates must already hold work authorization in US and be able to maintain that status without the need for future sponsorship
Preferred
Master's degree in above discipline preferred
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
Company
Moderna
Moderna Therapeutics is a biotechnology company that specializes in vaccines and drug development.
1001-5000 employees
Funding
Current Stage
Public CompanyTotal Funding
$4.56BKey Investors
Coalition for Epidemic Preparedness InnovationsAres ManagementU.S. Department of Health & Human Services
2025-12-18Grant· $54.3M
2025-11-20Post Ipo Debt· $600M
2024-07-02Grant· $176M
Leadership Team
Stephane Bancel
Founding CEO
Kenneth Chien
Co-Founder
Recent News
Morningstar.com
2026-01-09
Company data provided by crunchbase