System Owner, Commercial INT
ModernaTX, Inc.

Job Info

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The Role

In this role, you will be responsible for ensuring operability and reliability of GMP manufacturing process equipment located at the Moderna manufacturing facility in Norwood, MA. This individual will act as the owner of the Small Scale (mRNA or Plasmid or Fill Finish) process equipment throughout its lifecycle by working closely with Manufacturing, Facilities & Engineering, MS&T, Quality, and other applicable disciplines. Applicants should enjoy working in a fast-paced, dynamic, and innovative environment.

Here's What You'll Do:

• Ensure the process and process equipment meet compliance, safety, and business requirements on a day-to-day basis, as well as respond to alarms, Out of Specs, Out of Tolerances, etc. to ensure product impact assessments are performed as necessary.
  
• Troubleshoot equipment to determine root cause of failure modes, own Corrective/Preventative Actions & associated change controls, provide input on preventative maintenance plans, assess change controls, and spearhead continuous improvement initiatives.
  
• Own quality records such as Change Controls, Deviations, and CAPAs related to manufacturing process equipment, and employ high quality technical writing within the required quality systems to ensure the manufacturing schedule is not impacted.
  
• Maintain Engineering Turnover Packages, including specifications, component lists, operating manuals, and drawings for GMP process equipment and update as required.
  
• Act as an owner, provide engineering support for process equipment procurement and start-up at Moderna's Norwood manufacturing facility (Incubators, Centrifuges, Fermenters, Ultrafiltration, Chromatography, Manual & Robotic Filling Lines, Visual Inspection Machines, Label/Pack Lines, Buffer Prep Vessels, etc.).
  
• Participate on project teams through all phases of engineering projects related to process equipment including development of user requirements, conceptual design, detailed design, equipment procurement, construction, installation, start up, commissioning, validation, and qualification of facilities and/or equipment.
  
• Review design documentation from conceptual through detailed design, URS documents, and Engineering Turnover Packages, including specifications, component lists, operating manuals, and drawings for GMP process equipment and update as required.
  
• Perform additional duties as may be assigned.
  

Here's What You'll Need (Basic Qualifications)

• A bachelor's degree in Chemical or Mechanical Engineering or any other life science related technical field
  
• Equivalent military experience will be considered.
  
• Excellent interpersonal and communication skills (verbal and written). Expected to be able to present own work to peers and cross-functional managers and influence leadership decisions. Technical writing skills.
  
• Familiarity with Microsoft Excel, Word, and PowerPoint and basic statistical analysis techniques.
  
• Must be able use technical background to investigate issues using a structured problem-solving approach to determine root cause and develop effective corrective and preventative actions. Must be able to be able to find root cause and path forward for complex problems.
  
• Ability to interact well with other groups, take ownership of/follow through on assignments, drive results on multiple complex assignments simultaneously with minimal required direction from their supervisor.
  
• A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
  

Here's What You'll Bring to the Table (Preferred Qualifications)

• Prior experience in a GxP environment
  
• Prior experience in a Cell Processing/Manufacturing role
  
• Experience with Bioprocess Equipment (Ultrafiltration, Chromatography, TMIX, Single Use Mixers, Buffer Prep Vessels, Temperature Control Units, Fermenters, Reaction Vessels, etc.)
  

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 options
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Free premium access to fitness, nutrition, and mindfulness classes
• Exclusive preferred pricing on Peloton fitness equipment
• Adoption and family-planning benefits
• Dedicated care coordination support for our LGBTQ+ community
• Generous 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 thereafter
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• 401k match and Financial Planning tools
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Free parking or subsidized commuter passes
• Location-specific perks and extras!

About Moderna

Since 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 people are 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 leavesandaccommodations@modernatx.com. (EEO/AAP Employer)
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