Cellares
Senior Operational Technology Engineer
TLDR
Lead and support IT/OT operations while ensuring end-to-end infrastructure reliability and compliance in a fast-paced global cell therapy manufacturing lab environment.
We are seeking a hands-on Senior Operational Technology Engineer to lead and support IT/OT operations in a global cell therapy manufacturing lab environment.
This role is responsible for end-to-end OT infrastructure, including network and security on proprietary equipment, while ensuring secure access management, compliant change control, and 24x7 operations. The ideal candidate will combine deep technical expertise with strong leadership to drive system reliability, scalability, and regulatory compliance across multiple sites.
Candidates should enjoy working in a fast-paced, mission-driven environment, and be prepared to tackle a broad selection of challenges as the company grows.
Responsibilities
Manage and deliver OT systems and technology for the company’s industrial and cell manufacturing environments
Own and maintain a robust OT roadmap, including project objectives, prioritization, and implementation plans
Ensure OT production environments adhere to security best practices and comply with relevant regulations
Provide hands-on technical support and troubleshooting for production-related OT/IT issues, ensuring minimal disruption to 24x7 operations
Implement and monitor OT production systems to guarantee 24x7 uptime and reliability, including network, server, biotech manufacturing lab, and proprietary equipment
Develop and deliver training programs for new OT staff relating to production environment
Contribute to creating, maintaining SOPs, Policies, and Process
Lead and support GMP-related activities, including change control, system validation, qualification (IQ/OQ/PQ), and audit readiness
Own OT access management processes, including user provisioning, role-based access control, and periodic access reviews to ensure compliance with GxP, data integrity, and cybersecurity requirements
Ensure compliance with industry regulations, standards, and best practices related to OT and data security
Provide backup support to Corporate IT as needed to ensure continuity of enterprise IT services
Requirements
Bachelor's Degree in related field or proper training
7+ years of relevant experience
Proven experience in IT management with a manufacturing or industrial setting, with a strong focus on 24x7 operational support
Experience with monitoring, server management, and cybersecurity best practices
Experience with Fortigate firewalls, Hirschmann industrial switches, lab and warehouse equipment
Experience with various applications such as Nutanix Prism, SharePoint, and JIRA
Experience working in a biotech regulated environment
Knowledge of and experience with current Good Manufacturing Practices (cGMP) required
Ability to independently prioritize work and deliver results effectively in a fast-paced environment.
Ability to be a strong problem-solving skills and the ability to work under pressure
Requires availability for on-call support and extended hours during critical system issues to maintain 24x7 operations
Self-awareness, integrity, authenticity, and a growth/entrepreneurial mindset
This is Cellares
Cellares is the first Integrated Development and Manufacturing Organization (IDMO) and takes an Industry 4.0 approach to mass manufacturing the living drugs of the 21st century. The company is both developing and operating integrated technologies for cell therapy manufacturing to accelerate access to life-saving cell therapies. The company’s Cell Shuttle integrates all the technologies required for the entire manufacturing process in a flexible and high-throughput platform that delivers true walk-away, end-to-end automation. Cell Shuttles will be deployed in Cellares’ Smart Factories around the world to meet total patient demand for cell therapies at global scale. Partnering with Cellares enables academics, biotechs, and pharma companies to accelerate drug development and scale out manufacturing, lower process failure rates, lower manufacturing costs, and meet global patient demand.
The company is headquartered in South San Francisco, California with its commercial-scale IDMO Smart Factory in Bridgewater, New Jersey. The company is backed by world-class investors and has raised over $355 million in financing.
Leveling will be based on overall experience, education, and demonstration of knowledge throughout the interview process.
Cellares is pioneering the field of cell therapy manufacturing as the first Integrated Development and Manufacturing Organization (IDMO) focused on harnessing Industry 4.0 technologies. Its innovative Cell Shuttle platform automates and integrates the entire production process, enabling companies in academia, biotechnology, and pharmaceuticals to accelerate the delivery of life-saving therapies while reducing costs and operational failures.