Engineer I, Manufacturing Process Engineering

Moderna Therapeutics - Norwood, MA

Full-time - Entry Level

Norwood, MA

Professional, Scientific, and Technical Services

About the position

In this role, the Engineer I will play a key part in enhancing and leading our cutting-edge manufacturing processes and will serve as either a technical liaison for capital projects or for GMP manufacturing process equipment at Moderna's manufacturing facility in Norwood, MA. This role will support the reduction of manufacturing events, minimize user interventions, and enhance product quality and safety standards. The role involves direct engineering support, troubleshooting, and continuous improvement initiatives, ensuring operability and reliability of the equipment. The Engineer I will collaborate closely with MS&T, Facilities, Validation, and equipment End Users to ensure projects are executed efficiently and effectively, meeting objectives and timelines. Their contribution will be important in optimizing production capabilities and ensuring the seamless integration of new technologies and methods in manufacturing operations. The ideal candidate will thrive in a fast-paced, dynamic, and innovative environment. The Engineer I will provide direct engineering support for process equipment at Norwood, MA, including Ultrafiltration, Chromatography, Mix Skid, Single Use Mixers, Buffer Prep Vessels, Temperature Control Units, Fermenters, Reaction Vessels, CIP, Aseptic Filling Lines, Isolators, Visual Inspection Machines, Packaging Lines, Formulation Equipment, Analytical Equipment, Component Prep Equipment, and more. They will reduce manufacturing events, user interventions, and batch record excursions by ensuring optimal functionality of equipment and machinery. The Engineer I will drive results by owning and completing small projects with challenging timelines, with support from their manager. They will participate in all phases of engineering projects related to processing equipment, including design, equipment procurement, asset induction, construction, installation, start-up, commissioning, validation, and qualification of facilities and/or equipment. Additionally, the Engineer I will respond to alarms, Out of Specification Conditions, and Out of Tolerances and ensure product impact assessments are performed as necessary. They will troubleshoot equipment to determine root cause of failure modes, drive failure resolution, own Corrective/Preventative Actions and associated Change Controls. The Engineer I will own and maintain process equipment assets through CMMS, including preventative maintenance plans, calibration data sheets, spare parts, and work order workflows. They will also maintain quality records such as Change Controls, Deviations, and CAPAs related to manufacturing process equipment, and meticulously document all activities related to manufacturing setup, troubleshooting, and automated method updates per applicable SOPs and guidelines. Furthermore, they will develop and implement updates for automated methods of processing equipment, ensuring seamless integration and minimal disruption to ongoing operations. The Engineer I will work closely with the Quality Assurance team to ensure all manufacturing processes meet internal and external regulatory requirements, supporting deviation initiation, CAPAs, and out-of-tolerance investigations. They will ensure all manufacturing activities comply with health, safety, and environmental regulations, and support the Process Engineering On-call team with troubleshooting guidelines and investigation. Finally, the Engineer I will assist in the setup/changeover of manufacturing systems and processes, perform operational assessments to ensure procedures and tools are in place, and follow all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.

Responsibilities

• Provide direct engineering support for process equipment at Norwood, MA, including Ultrafiltration, Chromatography, Mix Skid, Single Use Mixers, Buffer Prep Vessels, Temperature Control Units, Fermenters, Reaction Vessels, CIP, Aseptic Filling Lines, Isolators, Visual Inspection Machines, Packaging Lines, Formulation Equipment, Analytical Equipment, Component Prep Equipment, and more.
• Reduce manufacturing events, user interventions, and batch record excursions by ensuring optimal functionality of equipment and machinery.
• Drive results by owning and completing small projects with challenging timelines, with support from their manager.
• Participate in all phases of engineering projects related to processing equipment, including design, equipment procurement, asset induction, construction, installation, start-up, commissioning, validation, and qualification of facilities and/or equipment.
• Respond to alarms, Out of Specification Conditions, and Out of Tolerances and ensure product impact assessments are performed as necessary.
• Troubleshoot equipment to determine root cause of failure modes, drive failure resolution, own Corrective/Preventative Actions and associated Change Controls.
• Own and maintain process equipment assets through CMMS (preventative maintenance plans, calibration data sheets, spare parts, work order workflows).
• Own quality records such as Change Controls, Deviations, and CAPAs related to manufacturing process equipment.
• Maintain Engineering Turnover Packages, including specifications, component lists, operating manuals, and drawings for GMP process equipment.
• Meticulously document all activities related to manufacturing setup, troubleshooting, and automated method updates per applicable SOPs and guidelines.
• Develop and implement updates for automated methods of processing equipment, ensuring seamless integration and minimal disruption to ongoing operations.
• Work closely with the Quality Assurance team to ensure all manufacturing processes meet internal and external regulatory requirements, supporting deviation initiation, CAPAs, and out-of-tolerance investigations.
• Ensure all manufacturing activities comply with health, safety, and environmental regulations.
• Support the Process Engineering On-call team with troubleshooting guidelines and investigation.
• Assist in the setup/changeover of manufacturing systems and processes.
• Perform operational assessments to ensure procedures and tools are in place.
• Follow all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.
• Execute tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOPs) and work instructions.
• Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.
• Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence.

Requirements

• Minimum Education: BS. or M.S. in Chemical or Mechanical Engineering or equivalent
• Minimum Experience: 0-3 years relevant experience in Facilities, Engineering, or Operations
• Ability to interact well with other groups and must be able to take ownership of and follow through on assignments.
• Must be able to use their technical background to investigate issues using a structured problem-solving approach to determine true root cause and develop effective corrective and preventative actions.
• 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 decisions. Technical writing skills required.
• Demonstrated ability to manage own time and deliver to program timelines.
• Experience evaluating production line performance such as OEE, reliability performance metrics such as MTBF and MTTF, and life cycle management.
• Familiarity with Microsoft Office Suite is required, and basic statistical analysis techniques are preferred.
• Ability to represent Moderna's interests, objectives, and policies in a professional and responsible manner.

Nice-to-haves

• Experience in a GMP environment preferred.
• A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

Benefits

• 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, and 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!