Hiring: Facilities Project Engineer, Product Development Company: Cryoport Systems Location: Irvine, CA Job Posted Time: 2026-09-12 11:48:36 Employment Type: Contract Target Skills & Keywords : AutoCAD, CAD, Microsoft Excel, Microsoft Office, NetSuite, Project Management, Salesforce, SolidWorks, Systems Design About the job Experience: •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. •5+ years preferred) supporting infrastructure for Medical Devices, Biopharmaceuticals, or Cell & Gene Therapy operations, including facility expansions, utility systems, and critical environment management. Required Skills: •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. •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 •Actively facilitate and support 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. Qualifications: •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. •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. •Air Handling, hydraulics, pneumatics associated with the manufacturing, construction, and power environments. Compensation: •Up to $140,000 based on experience + bonus + stock Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!