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
Skills Required
- 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
- Experience with monitoring, server management, and cybersecurity best practices
- Experience with various applications such as Nutanix Prism, SharePoint, and JIRA
- Knowledge of current Good Manufacturing Practices (cGMP)
What We Do
Cellares is revolutionizing cell therapy manufacturing. We are developing a one-of-a-kind solution, The Cell Shuttle, to overcome the challenges associated with manufacturing so these life-saving therapies are affordable and widely available to patients who can benefit. The clinical impact of cell therapy in treating cancer has been proven, but this therapeutic approach has several limitations, especially in manufacturing, leaving extremely sick patients waiting for treatment and desperate for hope. Since cell therapy is currently produced for a single patient at a time, it is expensive to manufacture, requiring significant time and resources, and is difficult to scale. Preclinical and clinical scientists, as well as commercial cell therapy manufacturers also lack the options to fully automate their manufacturing process quickly, safely, cost-effectively and at the scale they need. The Cell Shuttle is an automated and closed end-to-end manufacturing solution that is flexible and scalable, enabling customers to run exact processes specified for their cell therapy. Compared with the current manual manufacturing processes for cell therapy, the Cell Shuttle’s next-generation automated manufacturing solution has 10 times the scalability (meaning 10 times more patient doses can be produced simultaneously), enables a three-fold reduction in process failure rates and will reduce the per-patient manufacturing cost by up to 70 percent for most processes.
