Principal Engineer, Drug Product, Global Engineering
1 day ago
We are seeking a highly skilled Principal Engineer to lead the design, development, and validation of drug product manufacturing process equipment and facilities throughout our global footprint. As a key member of our team, you will be responsible for leading projects in the Drug Product Engineering discipline and Aseptic Operations, collaborating with cross-functional teams to ensure that drug products meet quality, safety, and efficacy standards.
Key Responsibilities- Lead the design and development of aseptic manufacturing processes for Drug Product facilities.
- Lead Front End Planning (FEP) activities for the fill finish equipment scope on capital projects and programs.
- Lead equipment vendor selection and assessments.
- Develop user requirements, design specifications, process parameters, and FMEA assessments.
- Develop and maintain contamination control strategies to prevent microbial contamination.
- Ensure all aseptic operations adhere to Good Manufacturing Practices (GMP) and other relevant guidelines.
- Lead strategies for aseptic process commissioning, qualification, and support Media Fills and process validation, support protocols development in compliance with regulatory requirements.
- Prepare and review technical documentation, including validation reports, standard operating procedures (SOPs), and regulatory submissions.
- Serve as a Subject Matter Expert and work closely with Manufacturing and other functional groups to implement and scale up aseptic processes.
- Provide technical leadership and guidance to junior engineers and others in equipment design, problem-solving efforts, and troubleshoot aseptic process issues.
- Identify new technologies in aseptic processing and sterile manufacturing technologies.
- Drive results by owning deliverables and assuring on-time milestones completion in capital projects.
- Mentor and train team members on best practices in aseptic operations.
- Ph.D. in Chemical Engineering, Mechanical, or a related field with 8+ years of relevant experience, or M.S. with 10+ years of relevant experience, or B.S. with 12+ years of relevant experience.
- Extensive experience in aseptic processing and sterile manufacturing.
- Proven track record of successful commissioning, qualification, validation, and commercialization of aseptic processes.
- Strong knowledge of GMP, ICH guidelines, and regulatory requirements for aseptic operations.
- Experience with various aseptic techniques and equipment (e.g., isolators, cleanrooms, sterilization methods).
- Excellent problem-solving and analytical skills.
- Strong project management and organizational abilities.
- Effective communication and interpersonal skills.
- Ability to work collaboratively in a cross-functional team environment.
- Proficiency in using aseptic process development and validation tools.
- Experience in large capital/expansion programs with direct design responsibility.
We offer a comprehensive and innovative suite of benefits, including highly competitive and inclusive medical, dental, and vision coverage options, flexible spending accounts, lifestyle spending account funds, family care benefits, 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, discretionary year-end shutdown, paid sabbatical, generous paid leave offerings, 401k match, financial planning tools, Moderna-paid life, LTD, and STD insurance coverages, and voluntary benefit options.
About ModernaSince our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
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