Consulting Engineer

We offer integrated, comprehensive solutions that address complex technical, clinical development, and safety and regulatory challenges, leveraging our deep scientific, medical, and regulatory expertise and real-world experience. Our goal is to help you complete projects efficiently and with less risk, leading to solutions for a healthier and safer world.

With a broad range of renowned scientific, medical, regulatory, and engineering specialists under one roof, we streamline your project and reduce your workload, so you can make sound, science-based decisions about human and environmental health issues.

BlueRidge Life Sciences is a growing family of companies providing a comprehensive suite of life sciences services, spanning toxicology, regulatory science, risk assessment, epidemiology, biostatistics, engineering, clinical research, health economics, pharmaceutical commercialization, and environmental consulting. Across these specialized areas, we collaborate to deliver science-driven solutions that support industries including pharmaceuticals, biotechnology, medical devices, chemicals, foods and consumer products. Our collective expertise helps clients navigate regulatory requirements, assess safety and efficacy, manage risks, and optimize pharmaceutical commercialization strategies.

If you’re ready to achieve your life science goals, there’s no better partner than BlueRidge Life Sciences.  

Job Description:

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.

Responsibilities

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

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Qualifications

• 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.

Additional Skills/Preferences

• 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.

Physical Requirements

• A significant portion of the job responsibilities will require computer work that involves the continuous use of the fingers, hands, wrists, and sitting for long periods of time.
• The position also requires frequent lifting and/or moving up to 50 pounds
• The position requires work in an office as well as travel to customers, suppliers, group meetings, etc.