Principal Engineer, MS&T - INT / Drug Product

About the position

As a Principal Engineer in MS&T, you will lead process development, equipment selection and design, technology transfer, process validation, and equipment implementation, playing a critical role in both clinical and commercial manufacturing success. You will drive process innovation, integrate cutting-edge AI solutions, and enhance manufacturing excellence to deliver groundbreaking therapies to patients. If you are passionate about pioneering AI-driven process improvements and influencing key manufacturing decisions, we invite you to join us in this exciting role.

Responsibilities

• Participate in the development, optimization, and validation of filling processes for mRNA vaccines across various container types.
• Collaborate with cross-functional teams to ensure alignment between process design and manufacturing requirements.
• Drive process improvements and decision making using data analytics, DoE, and other advanced tools.
• Participate in the development, optimization, and validation of visual inspection processes using both manual and robotic inspection technologies.
• Define equipment specifications to fit intended processes, including filling and inspection unit operations.
• Lead the creation and management of User Requirement Specifications (URS).
• Participate in equipment selection, vendor evaluations & technical negotiations, and Factory Acceptance Testing (FAT).
• Lead or contribute to User Acceptance Testing (UAT) and ensure smooth equipment implementation.
• Lead technology transfer of filling and visual inspection processes from development to clinical and commercial manufacturing sites.
• Partner with stakeholders to ensure seamless process integration and knowledge transfer.
• Lead technical discussions, risk assessments (FMEA), and root cause investigations.
• Author and review validation strategy, protocol, reports and regulatory submission documents.
• Provide technical support for formulation, labeling, and packaging operations.
• Participate in audits and health authority inspections as SME.

Requirements

• Bachelor's, Master's, or Ph.D. in Engineering, Pharmaceutical Sciences, or a related field.
• Minimum 10-12 years of experience in MSAT, process development, or manufacturing roles, preferably with mRNA vaccines, biologics, or sterile products.

Nice-to-haves

• Extensive experience in filling process development, optimization, and validation.
• Experience with visual inspection technologies (manual and robotic).
• Experience in equipment selection, design, and validation (URS, FAT, UAT).
• Familiarity with global regulatory guidelines (CFR 21, ICH, PDA standards).
• Proficiency in Continued Process Verification (CPV), Quality by Design (QbD), DoE, and advanced data analytics tools.
• Experience with AI (ChatGPT preferred) and modeling tools (e.g., CFD) for process innovation.
• Strong project management skills, including performing cost and ROI assessment.

Benefits

• Highly competitive and inclusive medical, dental and vision coverage options
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Free premium access to fitness, nutrition, and mindfulness classes
• Exclusive preferred pricing on Peloton fitness equipment
• Adoption and family-planning benefits
• Dedicated care coordination support for our LGBTQ+ community
• Generous paid time off, including vacation, sick time and holidays
• Volunteer time to participate within your community
• Discretionary year-end shutdown
• Paid sabbatical after 5 years; every 3 years thereafter
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• 401k match and Financial Planning tools
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Free parking or subsidized commuter passes