Facilities Project Engineer, Product Development (GMP)

Cryoport-Systems; Irvine (CA); On-site; USD 84,000 - 140,000; Full time

Job summary

Cryoport Systems is seeking a Facilities Project Engineer, Product Development in Irvine, CA to plan, design, and implement facility systems for GMP environments. The role focuses on optimizing equipment, utilities, and infrastructure, ensuring regulatory compliance and cost-effective performance across global supply chain centers.

You will collaborate with Engineering, Operations, Quality, and EHS to drive capital projects, maintain documentation, and support site selection, retrofitting, and

Qualifications

• 7+ years in program/project management for facility design/development.
• Experience with Biopharmaceuticals/Cell & Gene Therapies and regulatory environments.
• Leadership in multidisciplinary facilities teams and budget oversight.
• Knowledge of cGMPs, ISO cleanroom and validated systems.

Responsibilities

• Lead or support facility projects from planning through delivery within GMP settings.
• Collaborate with PD, Operations, Quality, Regulatory and Externals to define scopes and budgets.
• Develop and maintain SOWs, schedules, and validation documentation.
• Oversee design reviews, risk assessments, and vendor selection.
• Manage documentation, CAPEX tracking, and project KPIs.
• Coordinate with clients and contractors to ensure timely, compliant delivery.

Skills

Project management

Facilities engineering

Regulatory/compliance (cGMP)

Vendor management

Cost analysis / budgeting

Documentation / SOP development

Team leadership / collaboration

MS Project / project controls

Education

BA/BS in Engineering or Life Sciences/Biopharma

Masters degree (a plus)

LEED accreditation

Tools

AutoCAD

Autodesk Inventor

Inventor Vault

SolidWorks

MS Project

CRM systems (Salesforce)

Job description

Cryoport Systems is seeking a Facilities Project Engineer, Product Development in Irvine, CA to plan, design, and implement facility systems for GMP environments. The role focuses on optimizing equipment, utilities, and infrastructure, ensuring regulatory compliance and cost-effective performance across global supply chain centers.

You will collaborate with Engineering, Operations, Quality, and EHS to drive capital projects, maintain documentation, and support site selection, retrofitting, and