Facilities Project Engineer, Product Development

Position Summary

Cryoport Systems is a comprehensive supply chain partner for the life sciences industry, delivering specialized solutions to meet the challenges of the biopharmaceutical, cell and gene therapy, reproductive medicine, and animal health markets. Our offerings span logistics, Bio Services and biostorage, cryopreservation, and consulting, ensuring the highest standards of quality and reliability for sensitive materials. With our expansive platform of management solutions and decades of temperature-controlled supply chain expertise, Cryoport Systems helps Enable the Outcome™ by supporting certainty and precision in the supply chain, whether advancing groundbreaking therapies, supporting families on their reproductive journeys, or enhancing animal health programs.

• Collaborate cross-functionally with departments including Logistics, Bioservices, Quality, Project Management, Consulting, Integricell, Tec4
  
  Med, Finance/Accounting, EXCOM and Operations to develop and execute strategic plans for establishing new Global Supply Chain Centers. These centers support advanced logistics functions as well as specialized bioservices capabilities such as kitting, storage, cryopreservation and controlled-environment handling.
• Lead or support the selection process for external service providers–including architects, designers, engineering consultants, and contractors–ensuring alignment with project requirements, timelines, regulatory standards, and cost expectations.
• Define and document comprehensive facility and equipment requirements to support GMPcompliant operations. Develop detailed implementation plans and validation documentation in alignment with engineering and quality standards. Documentation responsibilities include, but are not limited to:
  Scope of Work (SOW):
  Clear definitions of work to be performed, deliverables, and service expectations for project contributors. Capacity Planning:
  Assessment of asset and infrastructure needs based on projected throughput, storage, staffing, and service levels. Facility Layouts and Infrastructure Design:
  Development and review of mechanical, electrical, and plumbing (MEP) drawings, as well as warehouse configurations, material flow maps, and layouts for critical functions such as shipping, receiving, emergency response, and requalification zones. Standardization:
  Identification and specification of preferred equipment and systems to ensure consistency, scalability, and ease of maintenance across global facilities. Preventive Maintenance Programs:
  Creation of maintenance protocols and schedules to ensure optimal equipment reliability and regulatory compliance. Operational Documentation:
  Drafting of detailed work instructions, SOPs, facility design and training materials to support safe and effective operation of facility systems and processes.
• Act as a key stakeholder and subject matter expert in facility readiness initiatives, ensuring that all aspects of facility design and setup meet operational needs, safety standards, and regulatory requirements, particularly within GMP-regulated environments.

• Proactively support the definition and quantification of project deliverables, tracking progress against key milestones to anticipate and resolve potential roadblocks before they impact timelines or resources.
• Engage early and consistently with the Product Development group (PD) to evaluate product design requirements, ensuring alignment with operational, regulatory, and scalability considerations for seamless integration into facility operations.
• Partner with cross‑functional Project Management teams to coordinate and optimize resource allocation, ensuring alignment with strategic…