Facilities Project Engineer, Product Development

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, BioServices 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.

POSITION SUMMARY

The Facilities Project Engineer, Product Development is responsible for planning, designing, implementing, and optimizing facility-related systems and processes to support efficient and compliant operations within supply chain centers and pharmaceutical-grade environments. This role focuses on improving the design, functionality, and operational performance of equipment, utilities, and infrastructure, ensuring alignment with current Good Manufacturing Practices (cGMP) and industry standards.

This role will review and lead the implementation of new construction or facility improvement projects, including contributing to site selection, reconfiguration, retrofitting, and expansion of equipment, machinery, buildings, and support systems. The Facilities Project Engineer, Product Development will analyze material, labor, and operational costs; develop and enforce procedures and engineering standards; evaluate and compare vendor or contractor bids; and support the overall reliability, safety, and functionality of the plant.

This position plays a strategic role in ensuring the facility meets operational, regulatory, and environmental requirements while supporting cross-functional collaboration with Engineering, Operations, Quality, and EHS teams.

PRIMARY RESPONSIBILITIES (include but are not limited to):

• Collaborate cross-functionally with departments including Logistics, Bioservices, Quality, Project Management, Consulting, Integricell, Tec4Med, 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.

Team Operations

• 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 timelines and successful execution toward time-tomarket goals.
• Contribute to the development of annual departmental budgets, and lead post-project evaluations to assess process effectiveness. Conduct cost variance analysis, compare actual versus projected metrics, and provide recommendations for continuous improvement and operational efficiency.
• Perform facility feasibility assessments, risk analyses, and infrastructure evaluations focused on utilities, environmental controls, and process workflows to mitigate risks during implementation and scale-up of new services or operational expansions.
• Collaborate with the Project Management team to design and maintain a process engineering dashboard using project management tools (e.g., MS Project), ensuring clear visibility of project status, deliverables, and dependencies.
• Lead cross-functional risk assessments to identify potential challenges early and ensure the successful implementation of mitigation and contingency plans across engineering, operations, and quality teams.
• Escalate critical risks and threats to project execution in a timely manner to functional management and senior leadership for strategic intervention.

• Maintain accurate and compliant project documentation in accordance with internal finance, accounting, and quality system policies, ensuring transparency and traceability.
• Capture and integrate lessons learned from completed projects into future planning cycles, promoting a culture of continuous improvement and operational excellence.
• Collaborate with leadership on site selection and lease negotiations as well as negotiations with any partners needed for site development efforts.

Project Management

• Support the full lifecycle of facility projects - including selection, planning, execution, and delivery - ensuring alignment with processing requirements, engineering standards, project goals, timelines, and budgetary constraints, while meeting broader business objectives.
• Lead capital improvement initiatives such as facility expansions, infrastructure upgrades, renovations, and utility enhancements, ensuring execution is aligned with operational and regulatory needs.
• Coordinate with cross-functional teams - including PD Engineering, Operations, Quality, Regulatory, IntegriCell and Bioservices - to secure the necessary expertise and resources for successful planning and execution of Product Development (PD) facility projects.

• Serve as a key communication hub between stakeholders by providing timely updates on current and upcoming projects, resource requirements, key milestones, and delivery timelines.
• Assist in the creation, tracking, and management of project budgets and scopes. Monitor variances, ensure accurate submission of timecards and work estimates, and maintain transparency across internal and external teams.
• Oversee contractor invoice reconciliation, validating that billed services match ap