Consulting Engineer

BlueRidge Life SciencesRemote - California, CA
Hybrid

About The Position

Modality Solutions, a BlueRidge Life Sciences Company, is an engineering company focused on providing distribution and supply chain services and testing to the pharmaceutical industry. We are the leading industry experts in cold chain engineering and trusted partners to biopharmaceutical companies and public health organizations. The pharmaceutical industry is a regulated, complex environment and we are looking for self-motivated highly capable team members to help us continue bringing innovation to our customers.

Requirements

  • Bachelor’s degree in engineering or packaging
  • Relevant course work or experience in engineering, thermodynamics, packaging, and/or logistics
  • Excellent interpersonal and communication skills.
  • Individuals must be able to respond to changing priorities and operate under short lead times, be able to identify problems and work toward solutions, and be able to influence without direct authority.
  • The successful candidate must be attentive to details and have strong organizational skills.

Nice To Haves

  • Mastery of MS-Office applications
  • Experience working in FDA-regulated industry; specifically, biotech, pharmaceuticals, or public health
  • Understanding of drug product development requirements and quality-by-design concepts
  • Experience or course work related to the application of risk management tools (e.g., HAZOP, FMEA, fault tree)
  • Experience in supply chain operations: shipping, warehousing, packaging.
  • Knowledge of regression analysis and advanced computer modeling techniques
  • Demonstrated skills in technical presentation and analytical problem solving
  • Demonstrated ability to successfully manage a multitude of tasks concurrently
  • Experience in project management.

Responsibilities

  • Contributes to achievement of project deliverables and maintenance of timeline.
  • Develops, executes, and communicates project plans and manages project scope, goals, and deliverables.
  • Supports the development, approval, and execution of a Supply Chain Validation program for our clients.
  • Maintains vigilance to Quality Management System and procedures and contributes to the development of the System.
  • Applies basic Risk Management principles to work.
  • Designs testing protocols, executes tests, and writes reports in compliance with applicable industry-best standards.
  • Participates in business development through engaging clients to progress work relationships and writing new quotes or proposals.
  • Maintains a professional and courteous relationship with all clients as well as lead meetings and present technical information to non-technical base.
  • Independently manage your own time and projects, ensuring timely drafting/review/approval of procedures, protocols, reports, etc.
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