Process Engineer III, System Owner Commercial, INT

The Role

In this role, the individual will be responsible for ensuring operability and reliability of cGMP manufacturing process equipment located at a new Moderna commercial manufacturing facility in Marlborough, MA.  The individual will act as the owner of the Commercial Scale (Plasmid, mRNA or Fill Finish) process equipment throughout its lifecycle by working closely with EHS, 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 operations and process equipment meet safety, compliance, 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 and any associated change controls, provide input on preventative maintenance plans, act as engineering subject matter expert to assess proposed change controls from other disciplines, and spearhead continuous improvement initiatives.

• Own quality records such as Deviations, CAPAs and Change Controls 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, spare parts 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 Marlborough manufacturing facility (Incubators, Centrifuges, Ultrafiltration, Chromatography, TFF, Manual & Robotic Filling Lines, Visual Inspection Machines, Label/Pack Lines, Buffer Prep Vessels, etc.).

• Participate on project teams throughout 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 cGMP process equipment and update as required.

• Perform additional technical engineering duties as may be assigned.

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

• A Bachelor’s degree with 5-8 years of experience or a Master’s degree with 2-5 years of experience in Chemical or Mechanical Engineering or any other life science related technical field.

• Excellent technical writing, 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.

• 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 and 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 Pharmaceutical Process Equipment (Ultrafiltration, Chromatography, TFF, Single Use Mixers, Buffer Filtration, Incubators, Reaction Vessels, Clean Utilities, 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 P