Facilities Project Engineer, Product Development
Job in
Irvine, Orange County, California, 92713, USA
Listed on 2026-10-19
Listing for:
Cryoport-Systems
Full Time
position Listed on 2026-10-19
Job specializations:
-
Engineering
Quality Engineering, Operations Management, Systems Engineer
Job Description & How to Apply Below
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, 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,…
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