[Remote] Senior Engineer II, Automation, INT

Other Jobs To Apply

Note: The job is a remote job and is open to candidates in USA. Moderna is a biotechnology company focused on creating a leading mRNA technology platform. The Senior Engineer II, Automation will lead the design, implementation, and lifecycle management of advanced manufacturing systems for Individualized Neoantigen Therapies, driving innovation in process automation and smart manufacturing initiatives.


Responsibilities

  • Define and implement automation architectures aligned with ISA-95 (Levels 0–3) and ISA-88 standards
  • Design scalable, modular systems to support manufacturing of individualized therapy
  • Lead CAPEX projects from concept through commissioning and transition into OPEX
  • Provide ongoing lifecycle support for automation systems across Moderna facilities
  • Partner with MSAT, Manufacturing, Process Engineering, Quality, IT, Facilities, and other stakeholders to define requirements and deliver solutions
  • Lead the automation design for novel and new technologies
  • Oversee deployment and support of DeltaV, PLCs, SCADA, AVEVA PI, and robotics systems
  • Support Factory Acceptance Testing (FAT), commissioning, and validation activities
  • Develop and maintain APIs and integrations across platforms (data lakes, WMS, ERP)
  • Enable data-driven manufacturing through connectivity and analytics-ready systems
  • Promote an AI/ML-forward mindset in system design and data utilization
  • Ensure adherence to 21 CFR Part 11, Annex 11, and data integrity requirements
  • Lead and support CSV (IQ/OQ/PQ) activities and risk assessments
  • Own change control processes and maintain documentation per GDP standards
  • Identify and implement process improvements to enhance reliability, scalability, and efficiency
  • Champion continuous improvement initiatives across automation systems
  • Provide technical leadership and mentorship to cross-functional teams included but not limited to automation, process engineers and manufacturing
  • Support initiatives involving robotics and fleet management systems

Skills

  • Bachelor's degree or master's Degree in engineering plus related field or relevant experience; a combination of education and experience may be considered
  • 9 - 12 years of solid experience working in combination of manufacturing and lab systems in Pharmaceutical/Biotechnology
  • Experience with translating requirements against ISA-95 & ISA-88 structure
  • Strong automation background in DeltaV Control System including both continuous and batch processes. Well verse in S88 batch recipe creation, implementation, and troubleshooting
  • Well verse working with industrial protocols including HART, Ethernet I/P, OPC and classic IO
  • Hands-on experience with middleware tools (e.g., Kepware, OPC servers)
  • Knowledge integrating in-line PAT systems with DCS
  • Knowledge of advanced data analytics with multi-variate software such as SIMCA
  • Familiarity with Robotics, PLCs, and SCADA systems
  • Experience developing RESTful APIs and system integrations
  • Experience in tech transfer processes between MSAT, Process Development, Technical Development, Process Engineering and Manufacturing
  • Strong background in CSV and regulatory compliance (21 CFR Part 11, Annex 11)
  • Experience authoring, reviewing and approving FRS, URS, CDS documentation
  • Experience with IQ/OQ/PQ validation process for digital manufacturing/lab systems and with computerized system validation activities according to 21 CFR Part 11, Annex 11 and other regulatory requirements
  • This position is site-based, requiring you to be at Moderna's site full-time. This position is not eligible for remote work
  • At Moderna, we are focused on delivering on our mission by enabling talent to thrive. For this role, we are currently unable to offer immigration sponsorship. Candidates must already hold work authorization in US and be able to maintain that status without the need for future sponsorship
  • Creative, analytical, and strong problem-solving skills
  • Ability to work independently and make sound and timely decisions to achieve expected results
  • Ability to react under pressure to any given situation that may arise, in a professional manner and with positive results, in support of a multi-location environment
  • Ability to work hard to effect change in a dynamic, high standards environment while maintaining a positive approach with management and peers
  • Strong interpersonal skills with the ability to build successful professional working relationships
  • Ability to work effectively in a cross-functional, fast-paced project environment
  • A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative

Benefits

  • Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs
  • A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
  • Family planning benefits, including fertility, adoption, and surrogacy support
  • Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
  • Savings and investment opportunities to help you plan for the future
  • Location-specific perks and extras
  • The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.

Company Overview

  • Moderna Therapeutics is a biotechnology company that develops medicines and vaccines based on messenger RNA (mRNA) technology. It was founded in 2010, and is headquartered in Cambridge, Massachusetts, USA, with a workforce of 1001-5000 employees. Its website is

    • Back to blog

    Common Interview Questions And Answers

    1. HOW DO YOU PLAN YOUR DAY?

    This is what this question poses: When do you focus and start working seriously? What are the hours you work optimally? Are you a night owl? A morning bird? Remote teams can be made up of people working on different shifts and around the world, so you won't necessarily be stuck in the 9-5 schedule if it's not for you...

    2. HOW DO YOU USE THE DIFFERENT COMMUNICATION TOOLS IN DIFFERENT SITUATIONS?

    When you're working on a remote team, there's no way to chat in the hallway between meetings or catch up on the latest project during an office carpool. Therefore, virtual communication will be absolutely essential to get your work done...

    3. WHAT IS "WORKING REMOTE" REALLY FOR YOU?

    Many people want to work remotely because of the flexibility it allows. You can work anywhere and at any time of the day...

    4. WHAT DO YOU NEED IN YOUR PHYSICAL WORKSPACE TO SUCCEED IN YOUR WORK?

    With this question, companies are looking to see what equipment they may need to provide you with and to verify how aware you are of what remote working could mean for you physically and logistically...

    5. HOW DO YOU PROCESS INFORMATION?

    Several years ago, I was working in a team to plan a big event. My supervisor made us all work as a team before the big day. One of our activities has been to find out how each of us processes information...

    6. HOW DO YOU MANAGE THE CALENDAR AND THE PROGRAM? WHICH APPLICATIONS / SYSTEM DO YOU USE?

    Or you may receive even more specific questions, such as: What's on your calendar? Do you plan blocks of time to do certain types of work? Do you have an open calendar that everyone can see?...

    7. HOW DO YOU ORGANIZE FILES, LINKS, AND TABS ON YOUR COMPUTER?

    Just like your schedule, how you track files and other information is very important. After all, everything is digital!...

    8. HOW TO PRIORITIZE WORK?

    The day I watched Marie Forleo's film separating the important from the urgent, my life changed. Not all remote jobs start fast, but most of them are...

    9. HOW DO YOU PREPARE FOR A MEETING AND PREPARE A MEETING? WHAT DO YOU SEE HAPPENING DURING THE MEETING?

    Just as communication is essential when working remotely, so is organization. Because you won't have those opportunities in the elevator or a casual conversation in the lunchroom, you should take advantage of the little time you have in a video or phone conference...

    10. HOW DO YOU USE TECHNOLOGY ON A DAILY BASIS, IN YOUR WORK AND FOR YOUR PLEASURE?

    This is a great question because it shows your comfort level with technology, which is very important for a remote worker because you will be working with technology over time...