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Senior Manufacturing Engineer
1 month ago
Moderna is seeking a highly skilled Engineer II, MS&T to join our DNA and Chemistry Manufacturing Sciences & Technology (MS&T) team. As a key member of our team, you will be responsible for ensuring the robust technology transfer and technical support of our plasmid and custom nucleotide platforms in clinical and commercial drug substance cGMP manufacturing.
Key Responsibilities- Partner with stakeholders in Process Development, Manufacturing Operations, Regulatory and Quality to ensure all aspects of technology transfer and technical support are successfully executed.
- Provide engineering support for process equipment used at Moderna's Norwood cGMP manufacturing facilities.
- Follow all relevant GMP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.
- Practice and promote safe work habits and adhere to safety procedures and guidelines.
- Execute tasks precisely as defined in internal guiding documents, including standard operating procedures (SOPs) and work instructions.
- Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.
- Utilize the manufacturing support systems and equipment as required, including SAP, VEEVA, Delta V, Syncade, LIMS, and CMMS.
- Support technology transfer projects, including coordination of process information exchange, documentation of process parameters, and tracking process performance.
- Independently provide basic technical support of cGMP manufacturing, including authoring of simple technology transfer documents, change control, manufacturing investigations, and helping validation activities.
- Analyze manufacturing performance through data review and analyses, establishing and maintaining data repositories.
- Collaborate with process development on studies to determine root cause for basic deviations.
- Lead a cross-functional team for moderately complex troubleshooting and operational improvements to manufacturing equipment.
- Lead design and engineering of basic disposable systems used in bioprocessing, including aseptic bioprocessing bags and tubing manifolds.
- Execute basic studies to demonstrate equipment fit and process performance.
- Author and execute protocols supporting process characterization and equipment scale up in cGMP Manufacturing.
- Bachelor's Degree in a STEM field (preferably with 3-5 years of industry experience) or Master's Degree with 1-2 years of industry experience.
- Working understanding of GMP regulations.
- Process development or operational experience in bioprocessing unit operations, such as fermentation, enzymatic reaction, chromatography, or tangential flow filtration.
- Knowledge of data management and statistical analysis.
- Excellent judgment and ability to communicate manufacturing issues in a scientifically sound way.
- Excellent communication skills, verbal and written.
- Ability to manage projects and adapt in a fast-paced environment.
- Ability to collaborate in a dynamic, cross-functional environment.
Moderna is a leading mRNA technology platform company that is committed to changing the future of medicine. We believe in giving our people a platform to change medicine and an opportunity to change the world. Our company culture is built on the values of belonging, inclusion, and diversity, and we are proud to be an equal opportunity workplace and an affirmative action employer.