Principal Engineer – MS&T – INT / Drug Product
| Company | Moderna |
|---|---|
| Location | Norwood, MA, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s, PhD |
| Experience Level | Senior, Expert or higher |
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.
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, including tech transfer, process optimization, and troubleshooting.
- Participate in audits and health authority inspections as SME.
Preferred Qualifications
- Extensive experience in filling process development, optimization, and validation.
- Visual inspection technologies (manual and robotic).
- Equipment selection, design, and validation (URS, FAT, UAT).
- Process validation, EMPQ, and media fills.
- Regulatory compliance and contributions to PPQ and BLA filings.
- 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.
- Familiarity with labeling and packaging processes.
- Experience with AI (ChatGPT preferred) and modeling tools (e.g., CFD) for process innovation.
- Strong project management skills, including performing cost and ROI assessment, balancing timeline, budget, innovation and operational efficiency.
- Effective collaboration and stakeholder management. Ability to influence internally and externally (suppliers), including negotiation.
- Excellent verbal and written communication skills for regulatory submissions, inspection support, and technical presentations.