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Senior Engineer, Manufacturing Execution Systems, Individualized Neoantigen Therapies

Senior Engineer, Manufacturing Execution Systems, Individualized Neoantigen Therapies
Company:

Modernatx


Details of the offer

The RoleModerna is seeking a Senior Engineer to drive the deployment of digital manufacturing systems at our Individualized Neoantigen Therapies manufacturing sites at a global scale. The Senior Engineer Syncade is responsible for designing, developing, and implementing Manufacturing Execution Systems (MES) solutions using the Syncade platform. This mid-to-senior level position requires experience in MES engineering, with a focus on the Syncade platform, as well as strong technical skills and the ability to work collaboratively with cross-functional teams.Here's What You'll DoDesign, develop, and implement MES solutions using the Syncade platformCollaborate with cross-functional teams (Manufacturing, Facilities and Engineering, MS&T, Quality, IT Infrastructure, and other groups) to gather requirements and develop project plans.Support system owners by executing projects including the addition of new technologies, unit operations and future technical upgrades.Ensure robust testing of new configuration features based on structure risk assessments. Identify opportunities to improve existing processes, equipment, systems, and infrastructure by both leveraging and setting industry best practices.Coordinate validation activities in collaboration with Manufacturing, Engineering, Validation, and QA.Develop and maintain GMP system documentation and manage supporting compliance activities.Provide technical leadership and guidance to junior engineers and project teams.Develop and maintain project documentation, including functional specifications and test plans.Troubleshoot and resolve technical issues related to MES systems and processes.Ensure compliance with regulatory requirements and industry standards.Additional duties as may be assigned from time to time.Here's What You'll Need (Minimum Qualifications)Bachelor's or master's degree in engineering, computer science, or a related field.5+ years of experience in MES engineering, with specific experience using the Syncade platform.Strong knowledge of MES concepts, including batch management, recipe management, and data collection.Experience with software development and programming languages such as C#, Java, or SQLExcellent communication and collaboration skills, with the ability to work effectively with cross-functional teams.Knowledge of regulatory requirements and industry standards such as FDA regulations, GAMP, and ISA-95.Strong leadership skills, with the ability to mentor and guide junior engineers and project teams.Here's What You'll Bring to the Table (Preferred Qualifications)Working understanding of cGMP and manufacturing operations and practices.Deep understanding of ISA 88 and ISA 95 industry standards.Deep understanding of Good Automated Manufacturing Practices (GAMP) and Computer System Validation (CSV).Excellent interpersonal and communication skills with ability to work collaboratively within a team of cross functional stakeholders to influence decisions at every level of the organization.Self-directed with effective analytical and problem-solving skills. Must be able to drive results on multiple complex assignments simultaneously in a fast-paced environment.Computer programming and recipe authoring using Emerson Syncade platform (preferred).Experience with Personalized Medicine preferred.Experience with Syncade MES preferred.A desire to make an impact as part of a high-growth, transformational company that isBold, Relentless, Curious, and Collaborative.Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:Highly competitive and inclusive medical, dental and vision coverage optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classesExclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous paid time off, including:• Vacation, sick time and holidays• Volunteer time to participate within your community• Discretionary year-end shutdown• Paid sabbatical after 5 years; every 3 years thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras!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 peopleare 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.We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.Moderna is a smoke-free, alcohol-free and drug-free work environment.Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at ****** . (EEO/AAP Employer) #LI-KG1-


Job Function:

Requirements

Senior Engineer, Manufacturing Execution Systems, Individualized Neoantigen Therapies
Company:

Modernatx


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