Facilities Project Engineer, Product Development

Cryoport Systems•Irvine, CA

12d

About The Position

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.

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).
Proven experience working with cross-functional teams and collaborating across business units as well as with clients.
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.
Understanding of regulated supply chains, especially those involving cold chain logistics and biologics handling, including facility requirements for temperature control, material segregation, and traceability.
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.
Air Handling, hydraulics, pneumatics associated with the manufacturing, construction, and power environments.
The ability to work in AutoCAD, Autodesk Inventor and Inventor Vault, or equivalent e.g. SolidWorks
Architectural and Manufacturing blueprints.
Plant engineering and budget management experience.
Proficiency in Microsoft Office (Excel, Project, Access and Power Point); ability to capture, analyze, and present complex experimental and product design data
Strong CAD design experience with Autodesk Inventor, Solidworks or equivalent
Experience with construction management and operations systems (Autodesk ACC, etc.)

Nice To Haves

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).
LEED accreditation.
Prefer previous experience with CRM (Salesforce, NetSuite) and Project Management Systems.

Responsibilities

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 GMP-compliant 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 timelines and successful execution toward time-to-market 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.
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 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.
Organize and facilitate external project meetings with clients and stakeholders throughout the project lifecycle, including kickoff meetings, discovery sessions, planning reviews, progress updates, and closeout discussions.
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.
Collaborate closely with internal teams, clients, contractors, vendors, and consultants to ensure accurate scoping, timely execution, and high-quality delivery of all facility-related projects.
Assist in defining standardized facility systems
Oversee facilities-related systems (e.g., CMMS, BMS, EMS, etc.) – design, selection, installation, maintenance, etc.
Ensure accurate drawings, documentation (URS, FRS), SOPs, and asset histories are maintained.
Track financial project documentation for continuous traceability.
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).
Drive the implementation of facility solutions that enhance operational efficiency, scalability, and readiness for new service offerings. Collaborate with stakeholders to ensure facility designs and expansions align with company goals and strategic direction.
Remain current with industry advancements, regulatory trends, and emerging technologies in facility design and operation to inform future infrastructure planning and continuous improvement.
Apply user-centered design principles and feedback from internal users to improve facility layouts, utilities access, and system integration, optimizing workflows and service delivery.
Ensure a standardized and effective facility design review process is in place and consistently utilized across all projects, incorporating cross-functional input to drive alignment, quality, and repeatable outcomes.
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