Facilities Project Engineer, Product Development

Cryoport Systems; Irvine (CA); On-site; USD 110,000 - 140,000; Full time

Job summary

Cryoport Systems in Irvine, CA seeks a Facilities Project Engineer, Product Development to plan, design, implement and optimize facility systems supporting CGMP-compliant biopharma operations. You will lead cross-functional projects for new centers, upgrades, and infrastructure, ensuring safety, reliability and regulatory alignment.

Responsibilities include coordinating with PD, Operations, Quality and EHS, managing budgets and schedules, evaluating bids, and developing standardized engineering

Qualifications

• BA/BS degree in Engineering, Life Sciences/Biopharma or related field; advanced degree a plus.
• 7+ years in client-facing/project management roles in facility design/development or equivalent leadership experience.
• Experience in Biopharmaceutical/Cell and Gene Therapies and IND/BLA processes is valued.
• Knowledge of cGMP environments and regulatory requirements for pharma facilities.

Responsibilities

• Lead cross-functional facility projects from planning to delivery within timelines and budgets.
• Coordinate with PD Engineering, Operations, Quality, Regulatory to ensure compliance and scalability.
• Develop and manage project budgets, resource plans and KPIs; monitor spending and variances.
• Oversee vendor bids, contract management, and closeout documentation; ensure proper documentation and validation.

Skills

Project management

Facilities engineering

Regulatory compliance

Leadership

Cross-functional collaboration

Education

Engineering degree

Master's degree a plus

Tools

Autodesk Inventor

SolidWorks

Autodesk ACC

CRM (Salesforce)

Job description

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.

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.

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.
• 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 approved work scope, direction, deliverables, and budget expectations.
• Manage and maintain a comprehensive project pipeline. Provide routine reporting on project status, risks, resource allocation, and financial metrics to support strategic planning, revenue forecasting, and operational budgeting.
• Lead the project closeout process, ensuring proper documentation, validation, and the identification of lessons learned and opportunities for continuous improvement to optimize future facility design and operational integration.

Systems & Documentation

• Assist in defining standardized facility systems
• Ensure accurate drawings, documentation (URS, FRS), SOPs, and asset histories are maintained.
• Track financial project documentation for continuous traceability.

Solution and Asset Development

• Play a key role in developing, training, implementing, and maintaining Facilities Engineering SOPs, Standards of Execution (SOEs), Work Instructions, templates, and checklists to support organizational excellence. Ensure consistent execution of infrastructure and utility projects, enabling the organization to scale effectively while maintaining high standards of quality, compliance, and repeatability across similar facility builds and modifications.
• Support the creation of technical consulting materials that communicate facilities-related capabilities, implementation timelines, and infrastructure value propositions to internal and external stakeholders (e.g., sales enablement tools, training assets, and presentations).
• Apply user-centered design principles and feedback from internal users to improve facility layouts, utilities access, and system integration, optimizing workflows and service delivery.

Key Performance Indicators

• Capture, consolidate and report of PD team KPIs including but not limited to project performance metrics (timeline, resources, budget), PD portfolio metrics (all project resource utilization analysis, project revenues, timelines, etc.).
• Assist with preparing KPIs for facility engineering / PD resource meetings - sufficient information on project health, resource status, budget health, as well as retrospective analysis of completed projects to serve as learnings for the team and developing baseline project plans

Qualifications And Education Requirements:

• BA/BS degree (in Engineering, Life Sciences/Biopharma or a related healthcare field is highly preferred but not required - advanced degree is a plus). Masters degree a plus.
• Proven 7+ years of work experience in client facing roles with ability to think dynamically and professionally in front of clients and with internal teams.
• 7+ years of experience in program/project management for facility design/development (completion of project management training a plus) or equivalent leadership/management/industry experience.
• Experience working with Biopharmaceutical/Cell and Gene Therapies across all areas of research, clinical and commercial phases of development is highly valued - as well as experience or understanding with IND and BLA creation and understanding the process to bring biopharmaceuticals to market (from research to clinical trials to commercialization and beyond).
• Preferred to have experience and/or awareness of pharmaceutical cold-chain and/or pharmaceutical packaging and validation experience - including custom product, packaging and accessory design, testing, and validation (including familiarity with ISO, IATA, ASTM and ISTA standards relating to the pharmaceutical supply chain).
• Proven leadership experience in managing multidisciplinary facilities engineering teams with a wide range of technical competencies. Strong focus on talent development, mentorship, and organizational growth.
• In-depth knowledge of regulatory requirements impacting facility design and operations in regulated industries, including cGMP environments and support for FDA-compliant infrastructure (e.g., ISO cleanroom classification, environmental monitoring, and validated systems).
• Direct facilities engineering experience (3-5+ years preferred) supporting infrastructure for Medical Devices, Biopharmaceuticals, or Cell & Gene Therapy operations, including facility expansions, utility systems, and critical environment management.
• Skilled in process mapping, responsibility frameworks (e.g., RACI), and workflow optimization to ensure clarity and efficiency across engineering and operational interfaces.
• Experience in tracking all project financial, billing, accounting and contract management to ensure budget maintenance and financial KPI tracking.
• Experienced with IT network design, security system design & AV design.
• Experience in managing projects in FDA-regulated industry or comparable experience in another regulated environment.
• LEED accreditation.
• Air Handling, hydraulics, pneumatics associated with the manufacturing, construction, and power environments.
• Architectural and Manufacturing blueprints.
• Plant engineering and budget management experience.
• Work travel is required.
• Proficiency in Microsoft Office (Excel, Project,Access and Power Point); ability to capture, analyze, and present complex experimental and product design data
• Prefer previous experience with CRM (Salesforce, NetSuite) and Project Management Systems.
• Strong CAD design experience with Autodesk Inventor, Solidworks or equivalent
• Experience with construction management and operations systems (Autodesk ACC, etc.)

Compensation:

Up to $140,000 based on experience + bonus + stock