Senior 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

  • A minimum of three years of relevant experience
  • Has led or leads several client meetings without assistance from upper management
  • Has experience creating lab document types and any additional consulting documents as needed
  • Frequently brings new business opportunities where available
  • Has knowledge on important technical documents and changes in industry trends
  • 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

  • Manages and plays an active role in testing projects including identifying risk and mitigation pathways, overseeing timelines and ensuring documentation is completed to an acceptable technical and quality standard.
  • Has an in-depth knowledge of the equipment and capabilities of each lab, and facilitates any processes involved with the handling of testing samples. Is able to recommend alternative test methods or create custom flexible designs and modifications to best suit client requests while keeping in mind vendors and the external services that can be provided.
  • Maintains a professional and courteous relationship with clients as well able to lead meetings without the assistance from a Director (if required) and understands the methodologies used by Modality Solutions and in the industry to best determine an appropriate scope of work.
  • Participates in business development through engaging clients to progress work relationships and writing new quotes or proposals.
  • Independently manages their own time and projects, ensuring timely drafting/review/approval of procedures, protocols, reports, etc.
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