Process Engineer I, Drug Product

The Role

In this role, you will be a key technical contributor responsible for the ownership, operability, and reliability of GMP Drug Product manufacturing process equipment at Moderna’s clinical drug product facility. This role supports component preparation, formulation, aseptic filling, inspection, and packaging activities. The engineer is accountable for ensuring equipment readiness, supporting deviation investigations, and driving continuous improvement while maintaining compliance with GMP standards. Success in this role requires strong cross-functional collaboration, technical aptitude, and a floor-focused mindset to ensure sustained operations and right-first-time execution.

Here’s What You’ll Do

• System Ownership & Equipment Support

• Serve as the System Owner for Drug Product process equipment including formulation, filling, inspection, labeling, and packaging systems.

• Ensure equipment compliance, availability, and readiness through proactive support and lifecycle management.

• Own and maintain assets in CMMS, including maintenance strategy, spare parts, and workflow coordination.

• Deviation, CAPA & Change Control Management

• Lead or support deviations, CAPAs, and change controls related to process equipment.

• Conduct equipment troubleshooting, root cause analysis, and implement corrective/preventative actions.

• Support alarm and out-of-specification response and assessment processes.

• Project & Continuous Improvement Support

• Support start-up, commissioning, and qualification activities for new process equipment and upgrades.

• Collaborate with project teams on development of URSs, design reviews, FAT/SAT, and equipment installation.

• Identify and lead equipment/process improvements aligned with site and operational objectives.

• Documentation & Compliance

• Maintain Engineering Turnover Packages (ETOPs), including equipment specifications, drawings, and manuals.

• Ensure technical documentation is current, inspection-ready, and aligned with GMP expectations.

• Author and revise SOPs and other documents as needed.

• Cross-Functional Engagement

• Collaborate closely with Manufacturing, MS&T, Facilities, Quality, and EHS to deliver operational support.

• Actively participate in campaign planning, readiness reviews, and operational floor activities.

• Represent Engineering in audits, inspections, and cross-functional forums.

• Additional duties as may be assigned from time to time

Here’s What You’ll Need (Basic Qualifications)

• Education: Bachelor’s degree in Engineering (Mechanical, Electrical, or other relevant life sciences field)

• Experience: Up to 2 years of engineering experience in a pharmaceutical/biotech manufacturing environment

Here’s What You’ll Bring to the Table (Preferred Qualifications)

• Familiarity with aseptic filling, inspection, and packaging equipment preferred

• GMP/GxP exposure desirable

• Knowledge of GMP regulations for parenteral manufacturing

• Proficiency with technical writing, deviation/CAPA systems, and equipment troubleshooting

• Strong interpersonal skills with ability to work across functions and drive results

• Competency in MS Office tools (Excel, Word, PowerPoint)

• A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

• This position is site-based, requiring you to be at Moderna’s site full-time. This position is not eligible for remote work.

At Moderna, we believe that when you feel your best, you can do your best work.  That’s why our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between.

• Best-in-class healthcare coverage, plus a suite of voluntary benefit programs to support your unique needs
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
• Lifestyle Spending Accounts to personalize your well-being journey
• Family planning and adoption benefits
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investment opportunities
• Location-sp