Engineer III, Drug Product, Manufacturing Science and Technology (MSAT), Sterile Filling
Description
This role focuses on sterile fill-finish operations for vials and pre-filled syringes (PFS) in a manufacturing setting. Responsibilities include supporting technical, compliance, and validation aspects, troubleshooting operations, applying knowledge of isolator systems, assisting with sterility assurance, and collaborating with cross-functional teams to ensure aseptic integrity and adherence to cGMP and safety regulations.
What We're Looking For
Support day-to-day operations for sterile filling of vials and PFS, including real-time troubleshooting and monitoring.,Apply foundational knowledge of isolator systems to assist in operational readiness and process validation efforts.,Collaborate with Engineering, Manufacturing Sciences and Technology (MS&T), Quality, and Operations teams to support end-to-end technology transfer and validation.,Assist with implementation of sterility assurance principles and contamination control strategies.,Contribute to the execution of media fill qualification exercises under supervision.,Ensure all activities are executed in accordance with cGMP, safety regulations, and Moderna's operational standards.,Support data gathering and analysis to inform process improvements within sterile operations.,Participate in drafting and reviewing SOPs and technical protocols.
Ideal Candidate
Bachelor's or Master's degree in Chemical Engineering, Biochemical Engineering, Biotechnology, or a related field.,2-4 years of experience in the biotech or pharmaceutical industry with a focus on sterile filling operations.,Experience with PFS and vial filling operations.,Strong understanding of isolator technology.,Experience with designing and supporting media fill activities.,Strong understanding of GMP regulations and guidelines.,Must already hold work authorization in the U.S.
Minimum Education
Bachelor's Degree, Master's Degree
Hard Skills
Soft Skills
Benefits
Special Commitments
Must already hold work authorization in the U.S.
About the Company
Moderna, Inc.
Moderna is a biotechnology company pioneering a new class of medicines made of messenger RNA (mRNA). The company's platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases.
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