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BS/MS degree in Bio/Chemical Engineering, Bio/Chemistry, Pharmaceutical Science, or related field Hands on experience with chromatography, ultrafiltration, normal flow filtration, and development of innovative unit operations Working knowledge of statistical design of experiments (DoE) and analysis of multivariate data Experience with analytics and biophysical characterization of nanoparticles is a plus Knowledge of cGMP, ICH, regulatory guidelines and QbD principles as they apply to risk management and product commercialization Demonstrated background of providing technical support to commercial manufacturing processes, including but not limited to, support of process investigations, implementation of pro-active process modifications and support of post-approval changes is a plus Knowledge of nucleic acid chemistry, lipid chemistry, and biology is a plus Ability to thrive in a diverse and fast paced environment Excellent written and verbal communication skills", "stars": 0.0, "medallionProgram": null, "location_flexibility": null, "work_location_option": null, "canonicalPositionUrl": "https://modernatx.eightfold.ai/careers/job/309257059139", "isPrivate": false}, {"id": 309256716337, "name": "Engineer II, System Owner, Small Scale", "location": "Norwood, Massachusetts", "locations": ["Norwood, Massachusetts"], "hot": 0, "department": "Engineering", "business_unit": "Jerh Collins", "t_update": 1702129005, "t_create": 1700006400, "ats_job_id": "R14699", "display_job_id": "R14699", "type": "ATS", "id_locale": "R14699-en", "job_description": "Provide direct engineering support and Subject Matter Expertise for process equipment in use at Norwood, MA (Ultrafiltration, Chromatography, Reaction Vessels, Temperature Control Units, Fermenters, Mixers, etc ) Serve as the Engineering System Owner for process equipment, including the development and improvement of maintenance procedures, spare parts lists, and training for technicians and manufacturing operators. Provide technical support and execution of EHS policies, procedures, and initiatives. Using risk-based approaches and a deep understanding of equipment, design and optimize unit operations for early and late-stage manufacturing processes. Drive results by owning and completing the subsequent projects including high quality technical writing within the required quality systems and meeting the project timelines to ensure the production schedule is not impacted. The Process Engineer will participate on project teams through all phases of engineering projects related to process equipment including conceptual design, detailed design, equipment procurement, construction, installation, start up, commissioning, validation, and qualification of facilities and/or equipment. Maintain Engineering Turnover Packages, including specifications, component lists, operating manuals, and drawings for GMP process equipment and update as required. Troubleshoot equipment to determine root cause of failure modes, independently drive failure resolution, owning Corrective/Preventative Actions and associated change controls. Own quality records such as Change Controls, Deviations, and CAPAs, related to manufacturing process equipment, as required. Provide input into assessing change controls, and continuous improvement initiatives. Minimum Education Requirement: A bachelor's degree in Chemical or Mechanical Engineering Minimum of 2 years of relevant experience as a Process Engineer Minimum of 2 years of experience in a GxP environment preferred. Experience with Bioprocess Equipment (Ultrafiltration, Chromatography, TMIX, Single Use Mixers, Buffer Prep Vessels, Temperature Control Units, Fermenters, Reaction Vessels, etc) Excellent interpersonal and communication skills (verbal and written) are required. Expected to be able to present own work to peers and cross-functional managers and influence leadership decisions. Technical writing skills required. Self-directed with effective analytical and problem-solving skills. Must be able use his/her technical background to investigate issues using a structured problem solving approach to determine true root cause and develop effective corrective and preventative actions. Must be able to be able to find true root cause and path forward for complex problems. Familiarity with Excel, Word, and PowerPoint are required and basic statistical analysis techniques are preferred. Ability to interact well with other groups and must be able to take ownership of and follow through on assignments. Must be able to drive results on multiple complex assignments simultaneously with minimal required direction from his/her supervisor.", "stars": 0.0, "medallionProgram": null, "location_flexibility": null, "work_location_option": null, "canonicalPositionUrl": "https://modernatx.eightfold.ai/careers/job/309256716337", "isPrivate": false}, {"id": 309256041628, "name": "Engineer I, MS&T", "location": "Norwood, Massachusetts", "locations": ["Norwood, Massachusetts"], "hot": 0, "department": "Manufacturing and Operations", "business_unit": "Jerh Collins", "t_update": 1702129671, "t_create": 1696204800, "ats_job_id": "R14404", "display_job_id": "R14404", "type": "ATS", "id_locale": "R14404-en", "job_description": "Provide expertise in bioprocessing unit operations and cGMP manufacturing, responsible for technical support, change control, safety observations, manufacturing investigations, and person-in-plant coverage for the INT process. Support process training for GMP operations and development of process understanding and expertise. Train and assist the manufacturing team in operational excellence projects driven by 5S, Lean Six Sigma, and similar programs. Participate in cross functional technical process support and investigation teams. Partner with Technical Development, Manufacturing, and Quality to enable and sustain cGMP processes. Be the technical lead supporting cGMP manufacturing activities. Be the subject matter expert for plasmid, drug substance, and lipid nanoparticle processes for the INT process. This includes troubleshooting process and equipment issues. Author deviation/investigation reports, technical reports, and manage technical CAPA/change controls. Establish and maintain process performance trending / metrics using digital information and statistical analysis tools. MS&T will be providing weekend coverage for Manufacturing and as part of the team you will need to be flexible to work a weekend day on a rotational basis Biochemical engineer, Chemical engineer, Biochemistry or Biology background. BS with 1 to 2 years of experience or MS with experience in a pharmaceutical or biotechnology company. Demonstrated knowledge of cGMPs and experience providing technical support in a cGMP manufacturing environment. Knowledgeable in at least one of the following areas: chromatography, membrane separations, fermentation, enzymatic reactions, and formulation. Technical agility. The capability to manage diverse technical areas. Ability to collaborate effectively in a dynamic, cross-functional matrix environment. Preferred: Experience in biologics process development and scale up / scale down. Preferred: Experience with single use bioprocessing technologies. Preferred: Proven track record of participating in cross functional teams. Preferred: Knowledge of digital cGMP tools. 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