Principal Engineer, Filling Equipment

The Role:

The Principal Engineer for DP Filling Equipment will report to the Director of DP Process Engineering, serving as the subject matter expert (SME) for the Filling and closing Drug Product Manufacturing Equipment at Moderna. The incumbent will lead DP primary filling, containment and sterile operations engineering discipline for Capital Projects throughout Moderna's global footprint for both Clinical and Commercial supply operations.

The role also involves providing guidance to existing manufacturing facilities, including contract manufacturing sites. The ideal candidate should possess knowledge of regulatory and performance requirements for process equipment used in the sterile filling and closing of pharmaceutical drug products.

The Filling Equipment Engineer will be expected to maintain timeliness, accuracy, and thoroughness throughout the project lifecycle, leading projects in the Fill and Finish Engineering discipline. This role requires the ability to manage multiple contractors and a portfolio of technical projects simultaneously.

This role is based in Norwood, MA and reports to the Director of DP Process Engineering. Travel to support global manufacturing expansion could be up to 30% at critical project phases.

Here’s What You’ll Do:

• Develop specifications for filling and closing equipment.

• Lead Front End Planning (FEP) activities for the filling and closing equipment scope on capital projects and programs.

• Contribute to/perform equipment vendor selection and assessments.

• Provide input to user requirements, design specifications, process parameters, and FMEA assessments.

• Own filling and closing best practices and functional standards that enable global standardization of process, equipment, and systems.

• Translate the business needs of the company into engineering solutions.

• Serve as a Subject Matter Expert in primary packaging.

• Independently execute, and direct others in the execution of, the design of processes and equipment.

• Identify new technologies for filling and closing primary packaging equipment.

• Drive results by owning and completing capital projects.

• Participate in all phases of engineering projects related to process equipment.

• Troubleshoot equipment to determine root cause of failure modes.

• Drive development of Engineering Turnover Packages.

Here’s What You’ll Bring to the Table:

• A Bachelor’s degree in Electrical, Mechanical, or relevant engineering discipline

• Minimum of 10 years experience as an Engineer

• Minimum 10 years of experience in a GMP environment

• A technical and regulatory background in DP filling and closing equipment in pharmaceutical industry.

• Experience in large capital/expansion programs with direct design responsibility

• Experience with a Thermoforming, Heat Sealing, Plunger Insertion Side Load and Top Load Cartoning, Flexible Packaging Line Design, Vision Inspection Systems, Serialization and on-line barcode printing and verification and coding,

• Working knowledge of Aseptic Filling, Freeze Drying, Automatic Inspection and Clinical Packaging Operations would be preferred.

• 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.

• 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 for complex problems. 

• Familiarity 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.

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 acc