Plant Engineer Iii

The Role:This role will be responsible for ensuring continuous improvement and sustained compliance of GMP manufacturing process equipment located at the Moderna manufacturing facilities. This position will provide engineering support for utilities and HVAC to the campus, support in the execution of day-to-day operation, projects, and troubleshooting. Lead investigations relating to non-conformance events in partnership with Quality, IT, and Manufacturing. Applicants should enjoy working in a fast-paced, dynamic, and innovative environment.Proven problem-solving skills with a proactive, field-based approach for project and deviation management required. Ability to develop and drive continuous improvement initiatives is essential. Strong technical writing, problem solving skills, data analysis, and development and implementation of effective corrective and preventative action based on investigations is required.Here's What You'll Do:Provide direct engineering support and Subject Matter Expertise for plant and clean utility system (purified water system, WFI, autoclaves, process gasses, HVAC, etc.) This includes serving as the system owner for plant and clean utility systems.Using risk-based approaches and a deep understanding of equipment, design and optimize unit operations for early-stage manufacturing processes.Lead and manage large sized, complex projects. Skills required to meet expectations of the role include high quality technical writing within the required quality systems and meeting the project timelines to ensure the production schedule is not impacted. Manage 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.Troubleshoot equipment to determine root cause of failure modes, independently drive failure resolution, owning Corrective/Preventative Actions and associated change controls.Candidate must be able to drive results on multiple complex assignments simultaneously with minimal required direction from his/her supervisor, in addition to reviewing and guiding the work and performance of contractors.Collaborate with Quality functions to streamline processes and remove obstacles to allow for agile and compliant project execution.Own quality records such as Change Controls, Deviations, and CAPAs, related to plant utility systems, as required. Provide input into preventative maintenance plans, assessing change controls, and continuous improvement initiatives.Here's What You'll Bring to the Table:Bachelor's degree EngineeringMinimum of 5 years relevant experience preferably as a Plant Engineer5 years of experience in a GxP biopharmaceutical operations environment preferred.Experience with plant and clean utility systems. 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.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. A comprehensive understanding of regulatory requirements and their applications in a cGMP environmentFamiliarity 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.Ability to represent Moderna's interests, objectives, and policies in a professional and responsible manner.Experience working with electronic systems and thorough understanding of 21 CFR part 11, 210, and 211 requirements.Experience interacting with representatives of regulatory agencies.Experience with facility, utility, systems, and equipment commissioning and qualification.Excellent written and oral English language skillsProject management experienceModerna 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-AG1-