Senior Engineer I, External MSAT

Location: Norwood, Massachusetts, United States. Hybrid 70/30 work model with significant in-office collaboration. Only U.S. persons are eligible due to U.S. export control requirements; visa sponsorship is not available.

Salary: $109,200–$174,600 per year, with potential eligibility for discretionary bonus, incentive compensation, or equity.

Company

hirify.global develops mRNA-based medicines and operates a global manufacturing and technology platform.

What you will do

• Support technology transfer of clinical and commercial products into contract manufacturing organizations across chemical and biologic modalities.
• Provide technical support for cGMP manufacturing, including transfer documentation, risk assessments, change controls, deviations, investigations, CAPAs, and product impact assessments.
• Oversee CMO validation activities through protocol review, execution support, and assessment of summary reports.
• Drive data review, trending, KPI definition, data repository development, and continued process verification monitoring to identify process drift.
• Lead cross-functional troubleshooting and continuous improvement across manufacturing processes and equipment.
• Collaborate with CMOs and internal Quality, Manufacturing, Technical Development, and Supply Chain stakeholders while maintaining GxP, SOP, documentation, and data integrity standards.

Requirements

• B.S., M.S., or Ph.D. in a technical discipline related to pharmaceutical manufacturing, such as Chemistry, Biochemistry, Chemical Engineering, or Pharmaceutical Engineering.
• 7–10 years of experience with a B.S. or 4–7 years with an M.S. in a pharmaceutical or biotechnology company.
• Strong GMP experience in a technical or engineering role within Manufacturing Operations or MSAT.
• Knowledge of data management tools and statistical analysis.
• Strong scientific judgment, communication skills, risk identification, and issue-resolution capabilities in a GMP environment.
• Ability to work in the United States as a U.S. person is required; non-U.S. persons cannot be sponsored for an export control license.

Nice to have

• Experience working with contract manufacturing organizations.
• Experience with data-driven manufacturing improvement and AI-driven analytics.

Culture & Benefits

• In-person collaboration supported through a 70/30 work model.
• Healthcare coverage and voluntary benefit programs.
• Fitness, mindfulness, and mental health support.
• Family planning benefits, including fertility, adoption, and surrogacy support.
• Paid vacation, volunteer days, sabbatical, global recharge days, and discretionary year-end shutdown.
• Savings and investment opportunities plus location-specific benefits.