Senior MSAT Engineer: Tech Transfer & Validation

RXinsider LTD.; Norwood (MA); On-site; USD 109,000 - 175,000; Full time

Benefits offered by this job

Healthcare coverage

Well-being resources

Family planning benefits

Generous paid time off

Equity opportunities

Job summary

Moderna is expanding its MSAT capabilities in Norwood, MA, and seeks a technically skilled professional to support technology transfer for clinical and commercial products. You will author transfer documentation, review changes, and ensure robust risk assessments, while maintaining data integrity and GMP compliance across CMOs.

In this role you will drive validation oversight, CPV monitoring, and cross-functional collaboration with Quality, Manufacturing, and Supply Chain to enable

Qualifications

• BS/MS/PhD in a technical discipline related to Pharmaceutical Manufacturing (Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Engineering, etc.).
• 10 years of experience or MS with 4 to 7 years of experience in a pharmaceutical or biotechnology company.
• Strong GMP experience in a technical/engineering role within Manufacturing Operations and/or MSAT (CMO experience is a benefit).
• Knowledge of data management tools and statistical analysis.
• Strong judgment and ability to communicate manufacturing issues in a scientifically sound and clear way, proposing data-driven options and recommendations.
• Highly collaborative team player able to work effectively with internal stakeholders and external partners/CMOs in a cross-functional matrix environment.
• Demonstrated ability to manage multiple priorities and drive projects to completion in a fast-paced environment.
• Demonstrated ability to proactively identify risks, escalate appropriately, and support issue resolution in a dynamic GMP setting.

Responsibilities

• Support technology transfer activities for clinical and commercial products into CMOs, ensuring seamless scale-up and execution.
• Provide technical support for cGMP manufacturing, including authoring technology transfer documentation and risk assessments.
• Author and own Moderna-led change controls, while reviewing CMO-owned changes to ensure scientific rigor, appropriate risk assessment, and clear implementation rationale.
• Review CMO deviations and investigations, ensuring robust root cause analysis, effective CAPAs, and comprehensive product impact assessments; act as SME to challenge and guide investigations.
• Provide technical oversight of validation activities at CMOs, including protocol review, execution support, and assessment of summary reports.
• Drive data review, trending, and continued process verification (CPV-style monitoring), establishing data repositories, defining meaningful KPIs, and identifying early signals or process drift.
• Lead cross-functional troubleshooting and continuous improvement initiatives across manufacturing processes and equipment.
• Build strong, trust-based relationships with CMO technical and quality teams, influencing without direct authority to deliver right-first-time outcomes.
• Collaborate closely with internal stakeholders across Quality, Manufacturing, Technical Development, and Supply Chain to ensure alignment and execution.
• Maintain alignment across global manufacturing sites through shared data, insights, challenges, and standardized solutions.
• Ensure strict adherence to GxP regulations, internal policies, and compliance standards.
• Execute tasks in accordance with SOPs, work instructions, and internal documentation standards.
• Uphold Good Documentation Practices and Data Integrity principles to ensure inspection readiness and audit support.
• Complete all required training within defined timelines and maintain qualification status.

Skills

GMP experience

Data management

Statistical analysis

Cross-functional collaboration

Communication

Risk assessment

Education

BS/MS/PhD in Pharmaceutical Manufacturing

10 years experience or MS with 4–7 years in pharma/biotech

Job description

Moderna is expanding its MSAT capabilities in Norwood, MA, and seeks a technically skilled professional to support technology transfer for clinical and commercial products. You will author transfer documentation, review changes, and ensure robust risk assessments, while maintaining data integrity and GMP compliance across CMOs.

In this role you will drive validation oversight, CPV monitoring, and cross-functional collaboration with Quality, Manufacturing, and Supply Chain to enable