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Moderna · 2 weeks ago

Principal Engineer, DP Packaging Equipment

Norwood, MA

Full-time

Onsite

Senior Level, Lead/Staff

$138K/yr - $248K/yr

12+ years exp

Moderna is a leading mRNA technology platform company focused on reimagining how medicines are created and delivered. The Principal Engineer will lead the Label and Secondary Packaging Engineering efforts for capital projects, providing technical guidance and driving alignment on procedures and standards within teams.

BiotechnologyGeneticsHealth CareMedicalPharmaceuticalTherapeutics

Comp. & Benefits

No H1B

U.S. Citizen Only

Responsibilities

Lead the development of labeling and packaging equipment specifications

Manage Front End Planning (FEP) activities, working cross-functionally to define scope, design, manufacturability, cost, capital, risk, and schedules for capital projects

Drive vendor selection and assessment processes for packaging equipment

Provide input into user requirements, design specifications, process parameters, and FMEA assessments

Establish and maintain best practices and functional standards for packaging to promote global standardization of equipment, processes, and systems

Translate business needs into engineering solutions, incorporating an understanding of both commercial and clinical secondary packaging requirements

Act as the Subject Matter Expert (SME) for secondary packaging, driving alignment on procedures and standards within internal and cross-divisional teams

Execute and direct the design of processes and equipment, leveraging innovative engineering techniques and benchmarking both internally and externally

Identify and evaluate new technologies for secondary packaging equipment and printed materials, conducting testing as part of the technical roadmap

Provide technical support to Moderna’s external supply manufacturing network, troubleshooting issues, recommending design improvements, and contributing to continuous improvement efforts

Lead and manage capital projects, ensuring adherence to project timelines and preventing delays

Participate in all phases of engineering projects, from conceptual design to commissioning, validation, and qualification

Troubleshoot equipment failures, contribute to preventative maintenance plans, assess change controls, and support continuous improvement initiatives

Review and guide the work of vendors and consultants while managing multiple complex assignments simultaneously

Develop and update Engineering Turnover Packages, including specifications, component lists, operating manuals, and drawings for GMP process equipment

Additional duties as may be assigned from time to time

Qualification

Packaging EngineeringGMP Environment ExperienceLabelingPackagingCapital Project ManagementThermoforming EquipmentHeat SealingFlexible Packaging DesignVision Inspection SystemsStatistical AnalysisMicrosoft OfficeTechnical WritingInterpersonal SkillsProblem Solving

Required

A Bachelor's or Master's degree preferably in Packaging, Mechanical or Automation Engineering. Other engineering degrees will be considered

Minimum of 12 years of relevant experience as a Packaging Engineer

Preferred

Minimum 5 years of experience in a GMP environment

A technical and regulatory background in labeling and secondary packaging requirement in pharmaceutical/Biotech 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, 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. Must be able to be able to find true root cause and path forward 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

A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative