Engineer II, Validation

Role Summary

Engineer II, Validation role responsible for performing commissioning, qualification and validation activities within Moderna's CQV program, owning capital projects delivery, site re-qualification and periodic review programs to ensure systems and equipment remain in an operational state of compliance.

Responsibilities

• Perform commissioning, qualification, and validation activities for Moderna‚Äôs GMP manufacturing facility across raw material, Drug Substance, Formulation, Drug Product, Finished Goods, and personalized medicine capabilities.
• Coordinate with external validation service providers and ensure commitments to key stakeholders are met.
• Maintain validated status of site facilities, utilities, equipment, and processes in accordance with internal procedures, regulatory requirements, and industry guidance.
• Support new equipment qualification activities for capital and operational projects.
• Assist investigations and reviews of deviations related to manufacturing process equipment, utilities, automation, computer systems, validation, and laboratory instruments.
• Provide support for equipment and systems in Moderna facilities (e.g., Controlled Temperature Units, analytical instruments, manufacturing unit operations).
• Support internal and external audits/inspections as part of the CQV program.
• Participate in continuous quality system improvements and support GMP Validation and Change Control Program improvements.
• Drive results by owning and completing validation initiatives/projects against identified timelines.
• Own quality records such as Change Controls, Deviations, CAPAs, and continuous improvement initiatives related to validation activities.
• Additional duties as assigned.

Qualifications

• Basic: B.S. in Life Science or Engineering (Mechanical, Computer Science, Biomedical, etc.); Master‚Äôs degree preferred.
• Minimum 2+ years in commissioning/qualification/validation/quality experience in cGMP manufacturing environments.
• Preferred: Strong understanding of validation principles for facilities, utilities, equipment, and systems (FUSE).
• Excellent technical documentation generation and review skills, ensuring content is technically sound and suitable for regulatory submission/inspection.
• Structured problem-solving ability to determine root causes and develop corrective and preventative actions.
• Excellent verbal and written communication skills; ability to present work to peers and managers and influence leadership decisions.
• Ability to work cross-functionally, take ownership of assignments, and drive multiple complex projects with minimal direction.
• Professional representation of Moderna‚Äôs interests and policies.
• Desire to contribute to a high-growth, transformational company; alignment with company values.
• Note: Immigration sponsorship not available for this role; candidates must hold work authorization in the U.S. without future sponsorship.

Skills

• Validation principles (FUSE)
• Technical writing and documentation
• Root-cause analysis and corrective actions
• Cross-functional collaboration and communication
• Project ownership and time management