Engineer II, Validation

Role Summary

Engineer II, Validation — perform commissioning, qualification and validation activities within the Moderna CQV program, owning delivery of capital projects, site re-qualification and periodic review programs to ensure systems and equipment remain in a state of compliance.

Responsibilities

• Perform commissioning, qualification, and validation activities for Moderna‚Äôs GMP manufacturing facility including raw material, Drug Substance, Formulation, Drug Product, Finished Goods, and personalized medicine capabilities.
• Work with external validation service providers and ensure commitment to key stakeholders.
• Maintain validated status of site facilities, utilities, equipment, and processes in accordance with internal procedures, regulatory requirements, and industry guidance/standards.
• Support new equipment qualification activities for capital and operational projects.
• Assist investigations and deviation reviews related to manufacturing process equipment, utilities, automation, computer systems, validation, and laboratory instruments.
• Provide support for equipment and systems in use at Moderna facilities (e.g., refrigerated units, analytical instruments, unit operations, bioreactors, etc.).
• Support internal and external audits/inspections as part of the CQV program.
• Participate in continuous quality system improvements and support implementing improvements in 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, CAPAs, and continuous improvement initiatives related to validation activities.
• Perform additional duties as assigned.

Qualifications

• Basic: B.S. in Life Science or Engineering (Mechanical, Computer Science, Biomedical Engineering, etc.); Master‚Äôs 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 suitable for regulatory submission/inspection.
• Structured problem-solving to determine root causes and develop corrective/preventive actions.
• Excellent interpersonal and communication skills; ability to present work to peers and management; technical writing skills.
• Ability to manage multiple complex assignments with minimal direction; take ownership and follow through.
• Professional representation of Moderna‚Äôs interests and policies; collaborative mindset.
• Authorization: Must hold US work authorization with no need for future sponsorship.

Skills

• Validation principles for facilities, utilities, equipment, and systems (FUSE).
• Technical documentation and regulatory submission readiness.
• Structured problem-solving and root-cause analysis.
• Cross-functional collaboration and stakeholder management.

• B.S. in Life Science or Engineering; Master‚Äôs preferred.

Additional Requirements

• No sponsorship available for this role; US work authorization required.