Job Summary:
Cellares is the first Integrated Development and Manufacturing Organization (IDMO) focused on mass manufacturing cell therapies. The Senior Operational Technology Engineer will lead and support IT/OT operations in a global cell therapy manufacturing lab environment, ensuring system reliability, scalability, and regulatory compliance across multiple sites.
Responsibilities:
โข Manage and deliver OT systems and technology for the companyโs industrial and cell manufacturing environments
โข Own and maintain a robust OT roadmap, including project objectives, prioritization, and implementation plans
โข Ensure OT production environments adhere to security best practices and comply with relevant regulations
โข Provide hands-on technical support and troubleshooting for production-related OT/IT issues, ensuring minimal disruption to 24x7 operations
โข Implement and monitor OT production systems to guarantee 24x7 uptime and reliability, including network, server, biotech manufacturing lab, and proprietary equipment
โข Develop and deliver training programs for new OT staff relating to production environment
โข Contribute to creating, maintaining SOPs, Policies, and Process
โข Lead and support GMP-related activities, including change control, system validation, qualification (IQ/OQ/PQ), and audit readiness
โข 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
โข Ensure compliance with industry regulations, standards, and best practices related to OT and data security
โข Provide backup support to Corporate IT as needed to ensure continuity of enterprise IT services
Qualifications:
Required:
โข Bachelor's Degree in related field or proper training
โข 7+ years of relevant experience
โข Proven experience in IT management with a manufacturing or industrial setting, with a strong focus on 24x7 operational support
โข Experience with monitoring, server management, and cybersecurity best practices
โข Experience with Fortigate firewalls, Hirschmann industrial switches, lab and warehouse equipment
โข Experience with various applications such as Nutanix Prism, SharePoint, and JIRA
โข Experience working in a biotech regulated environment
โข Knowledge of and experience with current Good Manufacturing Practices (cGMP) required
โข Ability to independently prioritize work and deliver results effectively in a fast-paced environment.
โข Ability to be a strong problem-solving skills and the ability to work under pressure
โข Requires availability for on-call support and extended hours during critical system issues to maintain 24x7 operations
โข Self-awareness, integrity, authenticity, and a growth/entrepreneurial mindset
Company:
Cellares is an Integrated Development and Manufacturing Organization dedicated to the automated, large-scale production of cell therapies. Founded in 2019, the company is headquartered in South San Francisco, USA, with a team of 201-500 employees. The company is currently Growth Stage.