The RoleBased at our new GMP Manufacturing facility in Norwood, MA, this position will be responsible for calibration, maintenance, and repairs of GMP/non-GMP process and support equipment. This position will also support troubleshooting, investigations, and reliability engineering for GMP/non-GMP process and support equipment in the Fill and Finish operation. This position will be the first responder to equipment issues and must follow through to ensure resolution by either self-performing the work or directing the activities of service providers.Here's What You'll DoPerform preventative and corrective maintenance activities and calibrations to support process equipment and systems, in accordance with established procedures and/or approved practices. Support efforts in developing remediation for follow-up and emergency work.Troubleshoot equipment and systems, and repair malfunctioning equipment. Work with equipment owners/engineers and direct the performance of work by equipment vendors.Maintain cGMP records, both paper based and electronic.Understand Asset Management and routine reliability concepts.Provide technical expertise for the maintenance and repair of manufacturing and support systems/equipment such as autoclaves, washers, formulation, vial/syringes lines, inspection, and label/packaging equipment.Perform calibrations in the following disciplines: Balances/scales, flow, temperature, conductivity, pressure, among others in a GMP/GXP environment.Maintain Facilities SOPs as required. Perform revisions and maintain author/owner responsibilities.Provide "on-call" support on a rotating basis. Support regular 24-7 operation of facility and respond to facilities issues as needed.Ensure that spare parts, tools, calibration standards and equipment are available to complete all assigned tasks.Respond to alarms and document activities in accordance with cGMP requirements. Working with equipment owners and develop remediation activities for alarms. Manage contract service providers; including scheduling, training on required SOP's, coordination and ensuring all work and documentation is performed in accordance with cGMP requirements.Administer and perform hazardous energy control procedures and confined space entry.Additional duties as may be assigned from time to time.Here's What You'll Need (Minimum Qualifications)AS or BS degree in a science/technical field or a technical trade school preferred.Minimum 7 years of relevant experience working in a regulated (cGMP preferred) environment.Thorough understanding of OSHA regulations related to LOTO, MSDS, Confined Space and Hot Work.Military training equivalent of above is acceptable.Experience with Metrology.Here's What You'll Bring to the Table (Preferred Qualifications)Understanding of PLC controls for simple troubleshooting is preferred.Excellent interpersonal and communication skills (verbal and written) are required. Ability to present own work to peers and cross-functional managers and influence leadership decisions.Technical writing skills required.Must have a customer service mindset.Must be able use technical expertise and judgement to investigate issues using a structured problem-solving approach to determine true root cause and path forward for complex problems. Demonstrated ability to learn new equipment/systems.Familiarity with Excel, Word, and PowerPoint.Ability to navigate computerized data and information management systems.Ability to interact well with other groups and must be able to take ownership of and follow through on assignments with minimal guidance. Must be able to drive results on multiple assignments simultaneously with minimal direction from management. Ability to represent Moderna's interests, objectives, and policies in a professional and responsible manner.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.As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.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 contact the Accommodations team at ****** . (EEO/AAP Employer) #LI-NB1-
